Gainesville, FL, United States
Exactech, Inc. recalls
33 recalls recorded since 2018, most recently on 3 February 2026. 17 are listed as ongoing. Status and classification are as published by the FDA.
Recalls33
Ongoing (FDA)17
Terminated or completed16
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 3 February 2026
- Reason
- Impactor handle may be missing cross-pin
- Distribution
- US: CA CO FL GA HI ID IL IN KS KY LA MA MD ME MN NV NY OH OK PR SC TN TX VA WI OUS: Australia France Germany Italy Japan Korea Spain Switzerland United Kingdom United Arab Emirates Slovenia
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1509-2026, Z-1510-2026
- Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05
- Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X
Ongoing Class II Medical devices
- Recall started
- 5 September 2025
- Reason
- Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
- Distribution
- U.S.: SC O.U.S.: N/A
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0536-2026, Z-0537-2026, Z-0535-2026
- Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46 Software Version: N/A Product Description: rTSA Reamer, 46mm Component: Not a component
- Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog Number: 301-11-11 Software Version: N/A Product Description: Pilot Tip Converter Piece Component: Not a component
- Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software Version: N/A Product Description: rTSA Reamer, 42mm Component: Not a component
Ongoing Class II Medical devices
- Recall started
- 15 August 2025
- Reason
- Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
- Distribution
- Worldwide - US Nationwide distribution in the states of CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MN, NV, NY, OH, OK, PR, SC, TN, TX, VA, WI and the countries of Australia, Austria, Brazil, Canada, Colombia, France, United Kingdom, Guatemala, India, Italy, Japan, Korea, Germany, The Ne
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2562-2025, Z-2561-2025
- Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 38MM HUM LINER +0), REF: 322-38-03 (145-DEG PE 38MM HUM LINER +2.5), REF:322-42-00 (145-DEG PE 42MM HUM LINER +0), REF: 322-42-03 (145-DEG PE
- Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/ 320-38-03,145-DEG PE 38MM HUM LINER +2.5/ 320-42-00,145-DEG PE 42MM HUM LINER +0/ 320-42-03,145-DEG PE 42MM HUM LINER
Ongoing Class II Medical devices
- Recall started
- 31 December 2024
- Reason
- Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
- Distribution
- U.S.: AR, CA, CO, FL, GA, HI, IL, IN, KS, KY, LA, MD, MN, NV, NY, OH, OK, PR,SC, TN, TX and VA O.U.S.: Argentina, Colombia, Germany, Guatemala, Japan and Spain
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1165-2025, Z-1166-2025, Z-1167-2025
- AcuMatch XLE Item Number / Product Description: 140-28-27 AM EHXL 0¿ LNR G 28MM 140-32-27 AM EHXL 0¿ LNR G 32MM 140-32-28 AM EHXL 0¿ LNR H 32MM 140-28-29 AM EHXL 0¿ LNR J 28MM 140-32-29 AM EHXL 0¿ LNR J 32MM 140-3
- Novation XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0 28MM 140-28-51 NV EHXLNTRL LNR G1 28MM 140-28-52 NV EHXL NTRL LNR G228MM 140-32-51 NV EHXL NTRL LNR G1
- Alteon XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0 28MM 140-28-51 NV EHXLNTRL LNR G1 28MM 140-28-52 NV EHXL NTRL LNR G228MM 140-32-51 NV EHXL NTRL LNR G1
Ongoing Class II Medical devices
- Recall started
- 26 April 2024
- Reason
- The AcuMatch L-Series 22mm Inner Diameter Bipolar Hip Liner lots were packaged without the specified ethylene vinyl alcohol (EVOH) layer. Between 2004 and August 2021, our packaging process utilized two different types of packaging materials: 1) Low Density Polyethylene (LDPE), Nylon, and EVOH, or 2) LDPE and Nylon without EVOH.
- Distribution
- Worldwide - US distribution in Puerto Rico and the countries of Great Britain, Japan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2236-2024
- Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19, SZ. L; b) 100-22-20, SZ. M; c) 100-22-21, SZ. N; d) 100-22-22, SZ. P; e) 100-22-23, SZ. R; f) 100-22-24, SZ.
Ongoing Class II Medical devices
- Recall started
- 18 April 2024
- Reason
- Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
- Distribution
- Worldwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2157-2024, Z-2155-2024, Z-2158-2024, Z-2156-2024
- OPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM; b) 200-05-26, 26MM; c) 200-05-29, 29MM
- OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02-35, 35MM; e) 200-02-38, 38MM; f) 200-02-41, 41MM;
- OPTETRAK, Advanced Patella, 3 Peg Implant, Item Numbers: a) 200-07-26, 26MM; b) 200-07-29, 29MM; c) 200-07-32, 32MM; d) 200-07-35, 35MM; e) 200-07-38, 38MM
- OPTETRAK One Peg Patella,, Item Numbers: a) 200-03-26, 26MM; b) 200-03-29, 29MM; c) 200-03-32, 32MM; d) 200-03-35, 35MM; e) 200-03-38, 38MM; f) 200-03-41, 41MM
Ongoing Class II Medical devices
- Recall started
- 6 March 2024
- Reason
- The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).
- Distribution
- Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, Malaysia, Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1409-2024, Z-1407-2024, Z-1421-2024, Z-1425-2024, Z-1420-2024, Z-1413-2024, Z-1415-2024, Z-1405-2024, Z-1404-2024, Z-1419-2024, Z-1403-2024, Z-1416-2024 and 12 more
- Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, RIGHT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-04-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-04-33, c)
- Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-33, c) 44, 47, 50, 53
- Exactech Equinoxe Constrained Humeral Liner: Item Numbers: a) 320-40-10, b) 320-40-13, Shoulder Arthroplasty
- Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number 320-46-10, b) +2.5mm, Item Number 320-46-13; Shoulder Arthroplasty
- Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty
- Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Numb
- Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head,
- Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02
- and 16 more product lines
Ongoing Class II Medical devices
- Recall started
- 21 November 2023
- Reason
- Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
- Distribution
- US NY, TX, IN, IL, MN, KY, VA, MD, TN, GA, NH, ME, SC, NV, FL, AR and Australia, Brazil, Chile, France, Germany, Guatemala, Italy, Japan, Korea, Slovenia, Spain, UK
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0577-2024, Z-0580-2024, Z-0579-2024, Z-0584-2024, Z-0581-2024, Z-0578-2024, Z-0582-2024, Z-0585-2024, Z-0586-2024, Z-0588-2024, Z-0583-2024, Z-0587-2024
- AcuMatch Hip System, Catalog Number 142-32-27
- Exactech Equinoxe Shoulder System, Catalog Numbers: a) 314-23-02, b) 314-23-03, c) 314-23-13, d) 314-23-14, e) 314-23-15, f) 314-24-22, g) 314-24-23, h) 314-24-24, i) 314-24-32, j) 314-24-33, k) 31
- Exactech Equinoxe Reverse Shoulder System, Catalog Numbers: a) 320-36-00, b) 320-36-03, c) 320-36-04, d) 320-36-10, e) 320-36-13, f) 320-38-00, g) 320-38-13, h) 320-40-00, i) 320-40-10, j) 320-42-00,
- Exactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009
- Exactech Novation Hip System, Catalog Numbers: 134-36-45
- Exactech Alteon Hip XLE Liner, Catalog Numbers: a) 01-030-40-0636, b) 01-030-40-0640, c) 01-030-42-0536
- Exactech Optetrak Knee System, Catalog Numbers: a) 200-02-26, b) 200-02-29, c) 200-02-32, d) 200-02-35, e) 200-02-38, f) 200-02-41, g) 200-03-32, h) 200-07-29, i) 200-07-32, j) 200-07-35, k) 204-21
- Exactech Truliant Knee System, Catalog Numbers: a) 02-012-35-3509, b) 02-022-35-1509, c) 02-022-35-1513, d) 02-022-35-3010, e) 02-022-35-3509, f) 02-022-35-3510, g) 02-022-35-3511, h) 02-022-35-4511, i
- and 4 more product lines
Ongoing Class II Medical devices
- Recall started
- 5 June 2023
- Reason
- The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction.
- Distribution
- Distribution was made to AR, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MD, ME, MN, NH, NV, NY, OH, OK, PA, SC, TN, TX, WI, as well as PR. There was no government/military distribution. Foreign distribution was made to Australia, France, and Japan.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2051-2023, Z-2050-2023
- Exactech Ergo Impactor Handle, Catalog #321-09-05.
- Exactech Shoulder GPS Impactor Handle, Catalog #531-07-05.
Ongoing Class II Medical devices
- Recall started
- 11 August 2022
- Reason
- Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
- Distribution
- Worldwide distribution: US (nationwide) and OUS (foreign) countries of: ARGENTINA, BRAZIL, CHILE, CHINA, COLOMBIA, ECUADOR, GREECE, GUATEMALA, INDIA, LEBANON PORTUGAL,PUERTO RICO,SPAIN
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1728-2022, Z-1727-2022, Z-1725-2022, Z-1731-2022, Z-1732-2022, Z-1729-2022, Z-1733-2022, Z-1734-2022, Z-1726-2022, Z-1730-2022
- GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH GXL 0 DEGREE LINER 28MM SZ E, REF 130-28-25 b. ACUMATCH GXL 0 DEGREE LINER 28MM SZ F, REF 130-28-26 c. ACUMATCH GXL 0 DEGR
- GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH +5MM LAT LINER 15 DEG 36MM ID, SIZE H, REF 138-36-08 b. ACUMATCH +5MM LAT LINER 15 DEG 36MM ID, SIZE J, REF 138-36-09 c. A
- GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. 0 DEG ACUMATCH CONSTRAINED LINER SZ E 28MM ID, REF 144-28-05; b. 0 DEG ACUMATCH CONSTRAINED LINER SZ F 28MM ID, REF 144-28-06; c.
- GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID,
- GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS, REF 130-32-51 b. NOVATION GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS, REF 130-36-52
- GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER, NEUTRAL, 28MM ID, GROUP 1 CUPS, REF 130-28-51 b. NOVATION GXL LINER, NEUTRAL, 32MM ID, GROUP 2 CUPS, REF 130-32-5
- GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 42, REF 106-22-42; b. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 44, REF
- GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH 0 DEGREE LINER 28MM 46MM, REF 130-28-05; b. ACUMATCH 0 DEGREE LINER 28MM 48MM, REF 130-28-06; c. ACUMATCH 0 DEGREE LINER
- and 2 more product lines
Ongoing Class II Medical devices
- Recall started
- 30 August 2021
- Reason
- Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CYPRUS, ECUADOR, FRANCE, FRENCH POLYNESIA, GERMANY, GHANA, GREAT BRITAIN, GREECE, GUATEMALA, INDIA, ITALY, JAPAN, JORDAN, KOREA, REPUBLIC
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0021-2022, Z-0025-2022, Z-0027-2022, Z-0024-2022, Z-0023-2022, Z-0022-2022, Z-0019-2022, Z-0020-2022, Z-0026-2022
- OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c.
- OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
- ARTHROFOCUS Polyethylene Tibial Inserts (Product Line: 256-12-XX, 256-13-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
- Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 35
- TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TR
- OPTETRAK Comprehensive Knee System custom devices labeled as the following: a. CUSTOM OPTETRAK ANGLED PS INSERT (Product Line: 900-06-XX, 900-08-XX); b. CUSTOM OPTETRAK CC TIBIAL INSERT (Product Line: 900-23-XX,
- OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK All-polyethylene CR Tibial Components, with Product Line Numbers: 200-11-XX, 200-12-XX, 200-13-XX, 200-14-XX, 200-15-XX, 200-16-XX; b. OP
- OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated
- and 1 more product lines
Ongoing Class II Medical devices
- Recall started
- 29 June 2021
- Reason
- Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
- Distribution
- Distribution US nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2119-2021, Z-2113-2021, Z-2123-2021, Z-2131-2021, Z-2130-2021, Z-2121-2021, Z-2129-2021, Z-2117-2021, Z-2132-2021, Z-2115-2021, Z-2128-2021, Z-2124-2021 and 10 more
- Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-40-XX, Novation GXL Liner, Neutral, 40mm. Orthopedic hip implant component.
- Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-32-XX, MCS +5GXL Liner 5/15 DEG and MCS GXL Liner 5/15 DEG. Orthopedic hip implant component.
- Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-40-XX, Novation GXL Liner, Lipped Ant, 40mm; Novation GXL Liner, Lipped, 40mm. Orthopedic hip implant component.
- Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-28-XX, Acumatch GXL 15 Degree, +5 Lat Liner, 28mm; Novation GXL 10 Deg Liner, G0, 28mm; and Novation GXL Liner, 10
- Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-22-XX, Novation GXL 10 deg Liner, G00, 22mm ID. Orthopedic hip implant component.
- Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-28-XX, Acumatch GXL 15 Degree Liner, 28mm; Novation GXL Liner, G0, 28mm ID; Novation GXL Liner, Lipped Ant, 28mm; a
- Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-40-XX, Novation GXL Liner, +5mm Lateralized, 40mm. Orthopedic hip implant component.
- Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-32-XX, Acumatch GXL 0 Degree Liner, 32mm; and Novation GXL Liner, Neutral, 32mm. Orthopedic hip implant component.
- and 14 more product lines
Completed Class II Medical devices
- Recall started
- 29 June 2021
- Reason
- Biolox Delta Femoral Head was packaged and labeled as 170-36-00 (36mm +0), but the device was marked as 170-36-03 (36mm +3.5).
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2251-2021, Z-2250-2021
- Exactech BIOLOX delta Femoral Head, 36m O.D. + 3.5mm, REF 170-36-03. Hip prosthesis component.
- Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis component.
Completed Class II Medical devices
- Recall started
- 11 May 2021
- Reason
- The HAT trial contains a retaining ring that has shown the potential to disengage during use.
- Distribution
- US Nationwide distribution in the states of AZ, CO, FL, NY, SC, and TN. There was no foreign/government/military distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1977-2021
- Humeral Augmented Tray (HAT) trials that are components of KIT-321HAT. Each tray contains 1 of each of the following catalog numbers for a total of 6 trials/tray: (1) HAT STD Left Tray Trial, Cat. #321-00-01; (2) HA
Ongoing Class II Medical devices
- Recall started
- 9 November 2020
- Reason
- Potential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primary, Press Fit, 11mm package.
- Distribution
- Distributed within the US to KS, OH, CA. International distribution to Australia and Germany.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0884-2021
- Equinoxe Humeral Stem, Primary, Press Fit, 11mm
Terminated Class II Medical devices
- Recall started
- 6 October 2020
- Terminated
- 13 November 2023
- Reason
- The product may be mislabeled.
- Distribution
- US consignees - AZ, CA, CO, FL, IL, IN, KY, LA, OH, OK, MD, ME, MN, NV, NY, SC, TN, TX, VA, WA, WI International consignees - Australia, Japan, and United Kingdom
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0459-2021, Z-0460-2021
- Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium
- Catalog 314-13-33, Equinoxe Cage Glenoid, Posterior Augment, Right, Medium
Terminated Class II Medical devices
- Recall started
- 25 September 2020
- Terminated
- 1 May 2023
- Reason
- The device may be incorrectly laser marked as a right stem, when it should have been laser marked as a left stem.
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of CA, CO, FL, IN, KY, NY, OH, TX, and Puerto Rico. The countries of Australia, Germany, France, Spain, India, Italy, South Korea, Singapore, UK, Luxembourg, and Brazil.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0307-2021, Z-0308-2021
- Equinoxe Platform Fracture Stem, 6.5mm, Left - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only.
- Equinoxe Platform Fracture Stem, 6.5mm, Right - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only.
Terminated Class II Medical devices
- Recall started
- 24 August 2020
- Terminated
- 1 May 2023
- Reason
- Exactech is recalling the Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit, because it may contain a incorrect length screw.
- Distribution
- Domestic Distribution: KS, CA, AR, NY, OH, IL, WI, AZ, LA, KY, VA, IN, TX, HI, MN, FL, TN, GA, ID, ME, CO, WA, SC. International Distribution: Austria, Australia, Germany, France, Spain, Italy, Japan, United Kingdom, Luxembourg, Netherlands, South Africa.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3020-2020, Z-3019-2020
- Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.
- Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 mm.
Ongoing Class II Medical devices
- Recall started
- 10 August 2020
- Reason
- The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm, were found to have a labeling error. Exactech is recalling the Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm because they were found to have a labeling error. The upper right corner of the label incorrectly identifies the implant size as 3 when the implant size is 4.
- Distribution
- Domestic: CO,FL,OK, PA. International: Chile
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2926-2020
- The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm.
Ongoing Class II Medical devices
- Recall started
- 27 January 2020
- Reason
- These Truliant Splined Stem Extension, 18mm x 120mm were found to have a labeling error. The upper right corner of the label incorrectly identifies the implant size as 17mm x 80mm when the implant size is 18mm x 120mm.
- Distribution
- US Nationwide distribution in the states of AZ, CO and FL.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1364-2020
- Truliant Splined Stem Extension, 18mm x 120mm - Product Usage: The devices are used in a cemented total knee prosthesis system, which provides femoral components, tibial inserts, stems, augments, and surgical instrumenta
Terminated Class II Medical devices
- Recall started
- 3 December 2019
- Terminated
- 11 October 2022
- Reason
- Labels with incorrect translations were identified by Exactech is a distributor in the Netherlands. The translations on the outer labels include the word " long" in all languages other than the original English version. The implants are standard length fracture stems.
- Distribution
- International distribution in the countries of Australia; Austria; Brazil; Canada; China; Colombia: France; Germany; Guatemala, India; Italy; Japan; Luxembourg; Netherlands; Singapore; South Korea; Spain; Sweden: United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0873-2020, Z-0872-2020
- Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 10.5mm, REF 304-22-11 - Product Usage: The Equinoxe Shoulder System is indicated for use and in skeletally mature individuals with degenerative diseases
- Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 6.5mm, REF 304-22-07 - Product Usage: The Equinoxe Shoulder System is indicated for use and in skeletally mature individuals with degenerative diseases
Terminated Class II Medical devices
- Recall started
- 2 October 2019
- Terminated
- 19 May 2023
- Reason
- Potential for the 2.4mm x 2.5 Fluted Pin Pouch to contain a single pin rather than four (4) as intended.
- Distribution
- US Nationwide distribution in the states of GA, NY, OH, VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0361-2020
- 2.4mm x 2.5 Fluted Pin Pouch; Catalog Number: 351-90-22; Orthopedic surgical instrument used in the implantation of the Vantage Total Ankle System - Product Usage: To assist the surgeon in the implantation of Vantage To
Terminated Class II Medical devices
- Recall started
- 10 September 2019
- Terminated
- 1 May 2023
- Reason
- Potential for the wire to fracture at the threads and remain in the glenoid.
- Distribution
- US Nationwide including the states of AR, AZ, CA, CO, FL, IL, IN, KS, LA, MN, NY, NY, OH, SC, TN, TX, VA, WA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0168-2020
- Ergo 3.2mm K-wire - Product Usage: The devices is used assist the surgeon in the implantation of Equinoxe Shoulder System components according to a conventional technique for total shoulder replacement. The wire is singl
Terminated Class II Medical devices
- Recall started
- 24 July 2019
- Terminated
- 31 May 2023
- Reason
- The threaded mechanism of the Threaded Offset Cup Impactor may be gritty and difficult to turn potentially due to entrapped blast media.
- Distribution
- US distribution to AR, CA, FL, IL, IN, NY, SC, TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2499-2019
- Threaded Offset Cup Impactor - Product Usage: To assist the surgeon in the implantation of Novation hip system components according to a conventional technique for total hip replacement. Specifically, these instruments a
Terminated Class II Medical devices
- Recall started
- 26 April 2019
- Terminated
- 22 April 2021
- Reason
- The Opteform Disc-30mm, Opteform Disc-45mm, and Opteform Disc-90mm were potentially exposed to higher temperatures than those documented in the IFU due to a failure of the cold storage equipment.
- Distribution
- OK, VA, FL
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1688-2019, Z-1690-2019, Z-1689-2019
- Opteform Allograft Disc, 30mm 3mm, 2cc, Catalog Number 600-03-30
- Opteform Allograft Disc, 90mm x 5mm, 22cc, Catalog Number 600-03-90
- Opteform Allograft Disc, 45mm x 5mm, 8cc, Catalog Number 600-03-45
Terminated Class II Medical devices
- Recall started
- 13 March 2019
- Terminated
- 22 April 2021
- Reason
- 2.5 Truliant Fit Trays were mismarked as 3
- Distribution
- US Nationwide Distribution in the states of AR, CA, OH, OK, IN, MN, NJ, TN, SC, FL
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1208-2019
- Truliant Tibial Fit Tray Cemented SZ 3F / 3T, Catalog Number 02-022-45-3030 Product Usage: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented The OPTETRAK Comprehensive Knee Systems are in
Terminated Class II Medical devices
- Recall started
- 5 December 2018
- Terminated
- 29 April 2021
- Reason
- Possibility that the Equinoxe Preserve Humeral Stem, 8mm, was inadvertently packaged with an Optetrak Knee System instructions for use (IFU) rather than the Equinoxe Preserve Humeral Stem IFU as intended .
- Distribution
- US Nationwide distribution in the states of AL,FL, IA, LA, MD, OH, SC.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0958-2019
- Equinoxe Preserve Humeral Stem, 8mm Product Usage: The Equinoxe Preserve Stems are indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where anatomic total arthropl
Ongoing Class II Medical devices
- Recall started
- 21 August 2018
- Reason
- The Equinoxe Reverse Drill Bit Kits may contain two 2mm diameter drill bits instead of one 2mm diameter drill bit and one 3.2mm diameter drill bit as intended.
- Distribution
- In the countries of Australia and France
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0012-2019
- Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery
Terminated Class II Medical devices
- Recall started
- 13 July 2018
- Terminated
- 22 April 2021
- Reason
- Exactech is recalling the Tibial Alignment Guide because the Global Trade Item Number (GTIN) on the device is incorrect. The GTIN on the device reads 10885862525629, when it should read 10885862525628.
- Distribution
- CA, OH, NY, OK, FL, TX, SC, Germany, Spain, Switzerland, and UK
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2966-2018
- Tibial Alignment Guide, REF 351-10-00 Vantage Fixed Ankle system components for ankle replacements.
Ongoing Class II Medical devices
- Recall started
- 8 May 2018
- Reason
- Potentially have non-conforming internal threads.
- Distribution
- US Distribution to Ohio only.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3209-2018
- Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis,
Terminated Class II Medical devices
- Recall started
- 9 October 2017
- Terminated
- 6 August 2019
- Reason
- Wrong device description of the label identifying the implant
- Distribution
- US Distribution to the states of : AL, CA, CO, FL, MD. and NY
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0538-2018
- Alteon HA Femoral Stem, Press-Fit, Extended Offset, Cementless, HA Coated, Collared, Size 5 All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacem
Terminated Class II Medical devices
- Recall started
- 31 August 2017
- Terminated
- 6 August 2019
- Reason
- Potentially mislabeled.
- Distribution
- Worldwide distribution in the states of OH, WI, AZ, GA, VA, CA, OK, MN, TN, ME, CO, SC, FL, AL, and Puerto Rico and country of Switzerland
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0414-2018, Z-0415-2018
- Equinoxe Cage, Glenoid, Alpha, Small Product Usage: The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or
- Equinoxe Cage, Glenoid, Alpha, Medium Product Usage: The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or
Terminated Class II Medical devices
- Recall started
- 11 July 2017
- Terminated
- 22 April 2021
- Reason
- Vix Bit may fracture during use.
- Distribution
- Worldwide Distribution: US states of Florida and California, Australia, France, Spain, and United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0603-2018
- Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.