Austin, TX, United States
Encore Medical, LP recalls
40 recalls recorded since 2018, most recently on 16 February 2026. 32 are listed as ongoing. Status and classification are as published by the FDA.
Recalls40
Ongoing (FDA)32
Terminated or completed8
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 16 February 2026
- Reason
- Due to packaging discrepancy with incorrect product size mixed up.
- Distribution
- GL112 Certus Medical LLC Indiana (IN) & Michigan (MI) 342-19-703 177T1057 EMPOWR 3D KNEETM INS, 3R 19MM, VE 1 MW001 Fox Medtech, LLC Colorado (CO), Wyoming (WY), Montana (MT), Counties in Nebraska 342-19-703 177T1057 EMPOWR 3D KNEETM INS, 3R 19MM, VE 1 NE190 Implant Medical Sales, Inc. New York (NY
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2700-2026, Z-2701-2026
- Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 342-19-703 Product Description: Enovis knee devices are intended for knee arthroplasty.
- Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 341-14-711 Product Description: Enovis knee devices are for knee arthroplasty.
Ongoing Class II Medical devices
- Recall started
- 15 January 2026
- Reason
- Knee and Humeral socket implants contain incorrect labeling.
- Distribution
- US Nationwide distribution in the states of VA, TN, IL, IN, MI, CO, WY, MT, RI, MA, NJ, PA, MO, OK, LA, FL, CA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1458-2026, Z-1460-2026, Z-1459-2026
- Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Model/Catalog Number: 509-00-432
- Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00-036
- Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: 341-16-707
Ongoing Class II Medical devices
- Recall started
- 5 January 2026
- Reason
- 942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery.
- Distribution
- US: TX, IA, MI, MS, MA, RI, NJ, PA, NY, MO, OK, PR, AL, CA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1233-2026, Z-1234-2026
- EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
- EMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, REF: 942-01-36H; Liner, 10 degree Hooded, HXe+, 36J, REF: 942-01-36J; Liner, 10 degree Hooded, HXe+, 40G, REF: 942-01-40G; Liner, 10 degree Hooded, HXe+, 32C
Ongoing Class II Medical devices
- Recall started
- 18 July 2025
- Reason
- Their is a potential that the reamer may kick or bind up during or immediately prior to use.
- Distribution
- US Nationwide distribution in the states of AL, AZ, CA, CO, FL, HI, IA, IL, IN, KS, KY, LA, MD, ME, NE, NJ, NY, OH, PR, RI, SC, TN, TX, UT, VA, WA, WI.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2547-2025, Z-2549-2025, Z-2546-2025, Z-2548-2025
- Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER BOSS DRILL, 6.5mm Model/Catalog Number: 804-06-312 Product Description: Material: S.S., Non Sterile
- Brand Name: DJO SURGICAL Product Name: FA S Altivate Reverse Glenoid Tray Model/Catalog Number: None Software Version: NA Product Description: Enovis" shoulder devices are intended for treatment of patients who are c
- Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER HEAD Model/Catalog Number: 804-06-311 Product Description: Material: S.S/Nitronic, Non-Sterile
- Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER SLEEVE Model/Catalog Number: 804-06-310 Product Description: Material: S.S/CoCrMo, Non-Sterile
Ongoing Class II Medical devices
- Recall started
- 9 July 2025
- Reason
- Knee implants contain incorrect labeling (size and/or side incorrect)
- Distribution
- US Nationwide distribution in the states of AL, AZ, CA, CO, FL, IA, IL, IN, KS, LA, NY, TN, TX.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2285-2025, Z-2286-2025
- Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16MM, VE Model/Catalog Number: 341-16-704 Product Description: Enovis knee devices are intended for treatment of patients who are c
- Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 7R 16MM, VE Model/Catalog Number: 342-16-707 Product Description: Enovis knee devices are intended for treatment of patients who are c
Ongoing Class II Medical devices
- Recall started
- 12 June 2025
- Reason
- Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued discovered via a customer complaint.
- Distribution
- RFK Medical Inc. Viriginia (VA) CE102 952-28-40E 2224A1124A EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 1 Valor Medical Solutions South Texas (TX) CE118 952-28-40E 2224A1124A EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 4 952-28-42F 2225A1124 EMPOWR Acetabular, Dual
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2147-2025, Z-2148-2025
- Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 Model/Catalog Number: 952-28-40E Software Version: NA Product Description: The EMPOWR Dual Mobility" system i
- Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD42 Model/Catalog Number: 952-28-42F Software Version: NA Product Description: The EMPOWR Dual Mobility" system i
Ongoing Class II Medical devices
- Recall started
- 2 June 2025
- Reason
- Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could result in a revision surgery if used.
- Distribution
- U.S Distribution to states of: AZ, IA, ID, IL, IN, LA, MI, MO, MS, NE, NY, OK, OR, PR, SD, UT, VA, and WA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2126-2025, Z-2125-2025
- Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 12MM, VE Model/Catalog Number: 341-12-711 Software Version: NA Product Description: Enovis" knee devices are intended for trea
- Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 10MM, VE Model/Catalog Number: 341-10-711 Software Version: NA Product Description: Enovis" knee devices are intended for trea
Ongoing Class II Medical devices
- Recall started
- 28 May 2025
- Reason
- Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
- Distribution
- At time of quarantine: RFK Medical Inc. Virginia (VA) CE102 506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 2 506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 1 Evolution Medical North Dakota (ND), Minnesota (MN), Colorado (CO), Utah (UT) C
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2008-2025, Z-2011-2025, Z-2010-2025, Z-2009-2025
- Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm Model/Catalog Number: 506-04-126 Software Version: NA Product Description: Encore Medical L.P. shoulder devices are intended for
- Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm Model/Catalog Number: 506-04-130 Software Version: NA Product Description: Encore Medical L.P. shoulder devices are intended for
- Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm Model/Catalog Number: 506-04-118 Software Version: NA Product Description: Encore Medical L.P. shoulder devices are intended for
- Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm Model/Catalog Number: 506-04-122 Software Version: NA Product Description: Encore Medical L.P. shoulder devices are intended for
Ongoing Class II Medical devices
- Recall started
- 18 December 2024
- Reason
- 5R 16MM knee tibial insert package may contain knee tibial insert 3R 14MM and vice versa, which may cause surgical delay to get a new product.
- Distribution
- US Nationwide distribution in the states of VA, MN, TX, WI, IA, IL, IN, SC, NY, MD, CA, FL, AZ, WA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0766-2025
- EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee Tibial Insert, 3R 14MM, VE, REF: 342-14-703
Ongoing Class II Medical devices
- Recall started
- 10 December 2024
- Reason
- Knee insert package may contain an acetabular system, which may cause surgical delay to get a new product.
- Distribution
- US Nationwide distribution in the states of IN, KS, CA, FL, NY, TX, AL, WA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0761-2025
- EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706
Ongoing Class II Medical devices
- Recall started
- 10 November 2023
- Reason
- Due to incorrect product/device within packaging.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0508-2024
- DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 Left 3D MATRIX COATED REF 243-01-108 DJO surgical EMPOWR KNEE", PRESS FIT BP MINUS, 8L REF 353-03-108 For the treatment of patients who ar
Completed Class II Medical devices
- Recall started
- 5 October 2023
- Reason
- Mislabeling
- Distribution
- US Nationwide distribution in the states of VA, TN, MN, IN, RI, ME, TX, LA, AL, FL, CA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0625-2024, Z-0626-2024
- Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797
- REF 130-03-738, All-Poly e + Patella, Domed Tri-Peg, 9x38mm, STERILE H2O2
Ongoing Class II Medical devices
- Recall started
- 29 September 2023
- Reason
- Knee punch handle tip is breaking during surgery due to the lack of heat treatment, which may lead to a disruption in surgery.
- Distribution
- US: VA, TN, MN, TX, IL, IN, KY, OH, SC, MS, RI, ME, NJ, NY, MD, CA, KS, LA, PR, AL, FL, GA, AZ, WA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0258-2024
- DJO EMPOWR Knee Punch Handle, REF: 801-05-040
Ongoing Class II Medical devices
- Recall started
- 25 September 2023
- Reason
- Two different humeral socket Insert devices were swapped during packaging, which could result in surgeons not having the correct device for surgery, which could cause a delay in surgery.
- Distribution
- US: MN, TX, IN, OH, SC, RI, ME, NJ, NY, KS, LA, FL, CA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0282-2024, Z-0281-2024
- RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm, REF: 509-01-436, orthopedic shoulder implant component.
- RSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus, REF: 509-03-432, orthopedic shoulder implant component.
Ongoing Class II Medical devices
- Recall started
- 6 September 2023
- Reason
- Coating hex did not engage with the Straight Mod Hexdriver or with the Hex Head Screw Driver
- Distribution
- U.S.: AZ, CA, FL, IN, KS, KY, ME, MN, MS, NJ, OH, Puerto Rico, RI, SC, TN, TX, VA, and WA O.U.S.: None
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0532-2024
- RSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204. DJO Surgical shoulder device.
Ongoing Class II Medical devices
- Recall started
- 22 August 2023
- Reason
- Reverse shoulder prosthesis package that should contain 5mmx30 screws could contain incorrect 3.5mmx30 screws. Use of incorrect screws could result in surgical delay and inadequate fixation.
- Distribution
- US: FL, IN, WI, IA, MN, KY, NY, AZ, RI, WA, OH, SC, VA, TX. OUS: MX
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0098-2024
- REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, REF: 506-03-130
Ongoing Class II Medical devices
- Recall started
- 22 August 2023
- Reason
- Knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed within the tray, which could result in surgeons not having the correct product for the surgery due to different anatomies (Hip vs Knee).
- Distribution
- US Nationwide distribution in the states of FL, CA, IN, HI, LA, MN, AZ, TX, NJ, PA, KS, TN, PR, SC, WA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0103-2024, Z-0102-2024
- EMPOWR Acetabular System, Liner, 10¿ Hooded, HXe+, 40H, REF: 942-01-40H
- EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705
Ongoing Class II Medical devices
- Recall started
- 4 August 2023
- Reason
- Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery
- Distribution
- US: AL, AZ, CA, CO, FL, IL, IN, KS, KY, LA, MA, MI, MN, MO, NC, NJ, NY, OH, PA, PR, RI, SC, TX, UT, VA, WA. OUS: Sweden, Australia, France, UK, Colombia, Germany
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2603-2023, Z-2604-2023, Z-2605-2023, Z-2606-2023, Z-2607-2023
- DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106
- DJO Surgical: Delta Ceramic Femoral Head, 44 mm + 4.0 mm, REF: 400-03-443
- DJO Surgical: CLP Hip, Stem, Polished Neck, Lateral Offset Implant, Size#3, REF: 426-11-030
- DJO Surgical: Reverse Shoulder System (RSP) Semi Humeral Socket Insert, 32mm, REF: 508-01-032; Baseplate, Glenoid HA-Coat, RSP, 6.5mm X 30mm, REF: 508-32-104; Reverse Shoulder System (RSP) Glenoid, Neutral Head W/ Retain
- DJO Surgical: Altivate Reverse, Humeral Stem, Small Shell, Size 6 x 108mm, REF: 533-06-108
Ongoing Class II Medical devices
- Recall started
- 28 February 2023
- Reason
- Patella drills are marked with incorrect diameter size of 5.6mm, when they should be 5.4mm. Porous patella overdrills are marked with incorrect diameter size of 5.4 mm, when they should be 5.6 mm. If the incorrect drill is selected during surgery, there is risk of the implant loosening, implant not properly fitting, and/or fractured bone.
- Distribution
- US: TX, IN, MD, CA, KS, AL, HI, WA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1384-2023
- EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella Drill, REF: 802-05-108
Ongoing Class II Medical devices
- Recall started
- 22 December 2022
- Reason
- Tibial insert implant large boxes were labeled small and the small boxes were labeled large. If the incorrect labeling is identified this could lead to surgical delay and if the surgeon does not recognize the size discrepancy between the insert label and the pin label, the surgeon may implant the incorrect pin size.
- Distribution
- US: MN, IL, IN, NY, FL
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1187-2023
- EMPOWR VVC KNEE TIBIAL INSERT, SIZE 6, 22MM, REF: 346-22-706; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 7, 22MM, REF: 346-22-707; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 8, 22MM, REF: 346-22-708; EMPOWR VVC KNEE TIBIAL INSERT, SIZ
Ongoing Class II Medical devices
- Recall started
- 12 August 2022
- Reason
- Hip liner implant boxes may contain knee inserts and knee insert boxes may contain hip liner implants, which may lead to implants not being available for surgeries, which may cause delays in surgery.
- Distribution
- US Nationwide distribution in the states of FL, IN, IL, KY, AZ, TX.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0125-2023, Z-0126-2023
- EMPOWR Acetabular System, Liner, 10 deg Hooded, HXe+ 40H, REF: 942-01-40H. Orthopedic implant component.
- EMPOWER 3D Knee Tibial Insert, REF: 341-14-708. Orthopedic implant component.
Ongoing Class II Medical devices
- Recall started
- 5 May 2022
- Reason
- A right, size 8, knee tibial insert package may include a mispackaged, left ,size 4, knee tibial insert. If implanted, a risk may include leaving debris in the joint space.
- Distribution
- U.S. Nationwide distribution in the states of TN, MN, IL, IN, SC, MS, CA, KS.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1257-2022
- DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708
Ongoing Class II Medical devices
- Recall started
- 28 June 2021
- Reason
- Complaints have been received concerning the humeral stem failing to mate with the broach handles for a shoulder device. This could result in delay of procedure or revision surgery.
- Distribution
- US: AL,AR,AZ,CA,CO,FL,GA,HI,IL,IN,KY,LA,MD,ME,MI,MN,MO,MS,MT,NM,NV,NY,OH,OK,OR,PA,PR,RI,SC,TN,TX,UT,VA,WA,WV OUS: N/A
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2331-2021
- AltiVate Anatomic Shoulder System for the following Part Numbers: 1. Part # 520-08-00, Rev. C., 2. Part # 520-10-000, 3. Part # 520-12-000, 4. Part # 520-14-000, 5. Part # 520-16-000
Ongoing Class II Medical devices
- Recall started
- 12 May 2021
- Reason
- Packaging mixup; There is a potential that packaging identified as 12mm knee prosthesis contains 16mm knee prosthesis and 16mm knee prosthesis packaging contains 12 mm knee prosthesis.
- Distribution
- US: Nationwide Distribution in the states of VA, MN, TX, IL, MS, CA, KS, LA, and GA OUS: None
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2103-2021, Z-2104-2021
- DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-12-711, Left Sz. 11 12mm, CE0086, Sterile H2O2, UDI: (01)00888912166980
- DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-16-711 Left Sz. 11 16mm, CE 0086, Sterile H2O2, UDI: (01)00888912167185
Ongoing Class II Medical devices
- Recall started
- 5 February 2021
- Reason
- Incorrect assembly of a subcomponent by a vendor and as a result, the windows provided to show the size are facing the opposite direction.
- Distribution
- U.S.: FL, IN, and MN O.U.S.: None
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1524-2021
- DJO EMPOWR KNEE Femoral Sizer
Ongoing Class II Medical devices
- Recall started
- 9 September 2020
- Reason
- Due to incomplete machining a small peg remnant on the top of the dome that protrudes above the surrounding porous coating causing the cup not to seat properly.
- Distribution
- U.S. Nationwide distribution including in the states of CA, MN, MS, NY, SC, TN and VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0135-2021
- EMPOWR Acetabular System *** EMPOWR Acetabular Cup, Cluster Hole, 54G *** Size 54G 54 mm Dia./Cluster Hole Alpha Code G Liner P2 Porous Coated REF 940-02-54G - Product Usage: are intended for treatment of patients who
Terminated Class II Medical devices
- Recall started
- 31 August 2020
- Terminated
- 19 April 2024
- Reason
- Product mislabeled. Use may result in a delay in surgery, stopping of surgery, and revision surgery.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0117-2021
- AltiVate Reverse Small Socket Insert, 44mm Semi Constrained - E-Plus, Part Number: 509-03-044 - Product Usage: Per IFU, DJO Surgical shoulder devices are intended for treatment of patients who are candidates for shoulder
Ongoing Class II Medical devices
- Recall started
- 7 August 2020
- Reason
- Product may be mislabeled with the size etched onto products differing from the size information shown on patient sticker labels. Risks associated with this issue may include the Surgeon implanting the incorrect size; significant physical impairment, discomfort and/or disruption of treatment of underlying condition; and the patient experiencing dislocation resulting in revision surgery.
- Distribution
- Distributed in the U.S. to: VA, MN, IN, RI, PA, NY, WA, KS, OK, FL, GA and CA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3021-2020, Z-3022-2020
- RSP Standard HUMERAL SOCKET INSERT, 44MM, HXe-Plus, Part No. 509-00-044
- RSP Standard HUMERAL SOCKET INSERT, 40 MM plus 4MM, HXe-Plus, Part No. 509-00-440
Ongoing Class II Medical devices
- Recall started
- 3 August 2020
- Reason
- There is a potential for the retaining pin of the tibial punch handle to become loose and fall out while impacting. If undetected, there is a potential of leaving debris in the joint space.
- Distribution
- U.S. Nationwide distribution including in the states of VA, TN, MN, TX, IL, IN, KY, OH, SC, RI, MD, PA, NY, CA, KS, OK, AR, LA, FL, AL, GA, AZ, NV, WA, MS, ME, NV and Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0060-2021
- DJO EMPOWR Tibial Knee Punch Handle Part No. 801-05-040 and 801-05-018 contained in Instrument Tray for EMPOWR Porous Knee - Product Usage: The Tibial Punch Handle is used in conjunction with one of three appropriately
Ongoing Class II Medical devices
- Recall started
- 19 June 2020
- Reason
- There have been issues experienced with the peg preparation steps, specifically drilling of the Femoral posterior peg. Upon drilling, the shaft portion of the drill may bind within the Posterior Peg drill guide. The extended length of the drill guide and tight tolerances to ensure accurate preparation seem to be contributing to this situation. There is a potential of a delay in surgery if this issue were to recur.
- Distribution
- US: AZ, CA, FL, GA, IL, IN, MI, MN, NY, TX, VA, and WA.. No OUS Consignees.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0479-2021, Z-0480-2021
- EMPOWR Partial Knee Peg Drill Guide; Model: 800-06-007.
- EMPOWR Partial Knee Peg Drill; Model: 800-06-008.
Ongoing Class II Medical devices
- Recall started
- 22 October 2019
- Reason
- The firm received complaints that the EMPOWR Acetabular Impactor Balls were fracturing/cracking during impaction which could cause debris to migrate or be left in the joint space.
- Distribution
- US Nationwide distribution including in the states of MN, VA, IL, IN, SC, N, TX, CA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1929-2020
- EMPOWR Acetabular System, Non-Sterile, Model Numbers 803-15-023 803-15-026 803-15-027 803-15-028 803-15-029 803-15-030 Product Usage: The EMPOWR Acetabular Impactor Balls is intended for use in joint replaceme
Ongoing Class II Medical devices
- Recall started
- 4 February 2019
- Reason
- The firm has received reports/complaints concerning the breakage of the tips of the locking femoral Impactor. Additionally, if the impactor is not seated correctly on the implant prior to impaction, this may cause off axis loading which can increase the risk of device failure. This could cause a delay in surgery. If the tip is not seen during surgery, long term risks may include an inflammatory response, infection, and/ or pain
- Distribution
- CO, WA, CA, UT, CA, TN, TX, MS, MO, AR, OK, LA, MN, IL, IN, KY, OH, MI, PA, SC, FL, PR, AL, GA, NM, AZ, NV, VA, RI, MD, ME PA, NY OUS: None
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0611-2020
- EMPOWR Locking Femoral Impactor , Part # 800-05-035, packaged in instrument tray FA EMP PAT TOOL KIT Part # 800-99-096
Terminated Class II Medical devices
- Recall started
- 21 September 2018
- Terminated
- 16 September 2020
- Reason
- Complaints regarding loose proximal body bolts or bolts that were found through x-ray as sitting above the proximal body and not properly seated. Patient risks may include: pain, dissociation, and possible revision surgery
- Distribution
- US: TN, MN, TX, CO, IL, IN, OH, SC, MS, MI, RI, PA, ME, NY, WA, MO, AR, OK, LA, AL, FL, GA, UT, AZ, CA, NV,.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1123-2019
- Exprt Precision System: Revision Hip, Proximal Body with Bolt, Lateral Offset, Sterile R, djo surgical, REF: 495-00-065, 495-00-075, 495-00-085, 495-01-065, 495-01-075, 495-01-085
Ongoing Class II Medical devices
- Recall started
- 19 September 2018
- Reason
- Manufacturing error, the drill bit shaft is unable to properly capture the drill bit pin. Failure of the drill bit shaft to capture the drill bit pin could result in the drill bit coming loose which could result in a delay in surgery or adverse patient reaction resulting in a revision surgery.
- Distribution
- US ( MS, NY, MO, OK, UT, AZ)
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2090-2019
- Flexible Drill Shaft, FMP Acetabular System Instrumentation REF 803-05-239 RX Encore Medical, L.P.
Ongoing Class II Medical devices
- Recall started
- 10 July 2018
- Reason
- The retaining ring on the neck trials has a potential to fail interoperatively.
- Distribution
- Distribution was made to CA, CO, MD, MN, OH, TX, and WA. There was no foreign/military/government distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1692-2020
- djosurgical Linear Neck Trials with Spring Sides, Standard, nonsterile, REF S-200635; and djosurgical Linear Neck Trials with Spring Sides, Lateral, nonsterile, REF S-200636. The firm name on the label is djosurgical, A
Terminated Class II Medical devices
- Recall started
- 26 June 2018
- Terminated
- 22 August 2023
- Reason
- A black, aluminum oxide coating may appear on the tray after cleaning. The black, aluminum oxide coating is not biocompatible.
- Distribution
- US Distribution to states of; AZ, CA, CO, FL, IN, NJ, NY, NV, MI, MN, MO, OH, RI, SC, TN, TX, UT and WA and country of; Japan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2600-2018
- Instrument trays used to store AltiVate Small Shell Trials (FA S ALTIVATE RSP HUM TRLS SM). Metal container with lid used to organize and transport instrumentation to be used in orthopedic surgery. Inner trays also
Terminated Class II Medical devices
- Recall started
- 14 May 2018
- Terminated
- 17 August 2020
- Reason
- After receipt of a product complaint for the labeling, it was determined that this device does not have FDA clearance.
- Distribution
- U.S. Distribution to states of: AZ, MO, MS, NY, OK, and UT; internationally to: Japan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2967-2018
- Foundation Modular Femoral Stem, Part Number, 220-10-110. Knee prosthesis component. The Foundation Revision Knee is a total knee system indicated as knee joint replacement for patients suffering from pain and dysfu
Terminated Class II Medical devices
- Recall started
- 30 January 2018
- Terminated
- 30 May 2023
- Reason
- Broken or missing screws and retaining clips. This may be due to screw tolerance and material strength of the trial.
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1241-2018
- AltiVate Reverse INSTRUMENTATION, HUMERAL SOCKET SHELL TRIAL, STANDARD, REF 804-06-152, Qty: 01, Encore Medical, LP Orthopedic surgical instrument. Product Usage: The humeral socket shell trial is used to replicate/
Completed Class II Medical devices
- Recall started
- 29 January 2018
- Reason
- It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540) is much larger on the trails than on the implants
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1259-2018, Z-1260-2018, Z-1258-2018, Z-1256-2018, Z-1257-2018
- Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 50mm, REF 804-07-500 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replaceme
- Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 54mm, REF 804-07-540 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint repla
- Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 46mm, REF 804-07-460 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replaceme
- Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 38mm, REF 804-07-380 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replaceme
- Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 42mm, REF 804-07-420 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replaceme
Terminated Class II Medical devices
- Recall started
- 12 December 2017
- Terminated
- 13 June 2022
- Reason
- The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the implant to be placed 2-3mm more posterior than intended.
- Distribution
- One medical device distributor in California.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0327-2018, Z-0326-2018, Z-0328-2018, Z-0329-2018
- EMPOWR Porous Knee System TIBIAL PUNCH, SMALL, REF 801-05-202, NON STERILE, Qty 1 For use in orthopedic surgery.
- DJO EMPOWR KNEE LOCKING TIBIAL PUNCH GUIDE, REF 801-05-042, NON STERILE, Qty 1 For use in orthopedic surgery.
- EMPOWR Porous Knee System TIBIAL PUNCH, MEDIUM, REF 801-05-203, NON STERILE, Qty 1 For use in orthopedic surgery.
- EMPOWR Porous Knee System TIBIAL PUNCH, LARGE, REF 801-05-204, NON STERILE, Qty 1 For use in orthopedic surgery.
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.