Winterthur, N/A, Switzerland
Zimmer GmbH recalls
27 recalls recorded since 2018, most recently on 20 May 2026. 20 are listed as ongoing. Status and classification are as published by the FDA.
Recalls27
Ongoing (FDA)20
Terminated or completed7
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 20 May 2026
- Reason
- Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2528-2026, Z-2531-2026, Z-2530-2026, Z-2527-2026, Z-2529-2026
- Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241
- Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040476
- Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040444
- Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240
- Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040242
Ongoing Class II Medical devices
- Recall started
- 11 May 2026
- Reason
- Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package.
- Distribution
- Refer to the attached ZFA 2026-00088_Initial Consignee List and ZFA 2026-00088_Initial Distribution History containing the distribution and the identification of the affected consignees.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2578-2026
- Brand Name: Persona Revision Product Name: Persona Revision¿ Trabecular Metal¿ Femoral Distal Augment Model/Catalog Number: 42-5572-066-10 Software Version: N/A Product Description: Persona Revision¿ Trabecular Metal
Ongoing Class II Medical devices
- Recall started
- 30 March 2026
- Reason
- Ten complaints have been received identifying issues at the time of use related to the package seal, including incomplete seals, wrinkles in the seals or peeling seals. Compromised sterile barrier may lead to clinically insignificant extension of surgery or infection leading to surgical intervention.
- Distribution
- US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MD, MI, MO, MS, NC, NE, NM, NY, OH, OK, PA, SD, TN, TX, UT, WA, WI and the countries of Canada, Australia, New Zealand, Malaysia, EMEA, Chile.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1946-2026
- Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and Spatula Model/Catalog Number: 00-5049-011-00 Software Version: N/A Product Description: Mixing Bowl and Spatula Component: N/A
Ongoing Class II Medical devices
- Recall started
- 2 December 2025
- Reason
- Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
- Distribution
- US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0972-2026, Z-0970-2026, Z-0975-2026, Z-0968-2026, Z-0982-2026, Z-0974-2026, Z-0971-2026, Z-0969-2026, Z-0980-2026, Z-0976-2026, Z-0983-2026, Z-0978-2026 and 5 more
- Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509420 Software Version: N/A Product Description: Affixus 9 mm, Length 420 mm, Right, Trochanter
- Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509380 Software Version: N/A Product Description: Affixus 9 mm, Length 380 mm, Right, Trochanter
- Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609320 Software Version: N/A Product Description: Affixus 9 mm, Length 320 mm, Left, Trochanteri
- Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509340 Software Version: N/A Product Description: Affixus 9 mm, Length 340 mm, Right, Trochanter
- Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815809280 Software Version: N/A Product Description: Affixus 9 mm, Length 280 mm, Left, Priformis N
- Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609300 Software Version: N/A Product Description: Affixus 9 mm, Length 300 mm, Left, Trochanteri
- Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509400 Software Version: N/A Product Description: Affixus 9 mm, Length 400 mm, Right, Trochanter
- Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509360 Software Version: N/A Product Description: Affixus 9 mm, Length 360 mm, Right, Trochanter
- and 9 more product lines
Ongoing Class II Medical devices
- Recall started
- 26 September 2025
- Reason
- Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E¿ Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the implant inside the package is a Size G 46 mm, and vice versa.
- Distribution
- US: OH, GA, WI, NE, IA, IL, CA, NY, MD, NC, PA, AL, TN, MI, WA, FL, TX, KS, NM, AZ, and CANADA, AUSTRALIA, NETHERLANDS
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0418-2026, Z-0419-2026
- Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 44 mm O.D., Size F, Bearing, Model/Catalog Number: 110031012; semi constrained hip prosthesis
- Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 46 mm O.D., Size G, Bearing, Model/Catalog Number: 110031013; semi constrained hip prosthesis
Ongoing Class II Medical devices
- Recall started
- 24 March 2025
- Reason
- The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Panama, Hong Kong, China.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1648-2025, Z-1646-2025, Z-1645-2025, Z-1649-2025, Z-1647-2025
- Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +0 Neck, Model Number 802802202; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncemented
- Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +3 Neck, Model Number 802602203; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncemented
- Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +0 Neck, Model Number 802602202; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncemented
- Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +3 Neck, Model Number 802802203; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncemented
- Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, -3 Neck, Model Number 802802201; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncemented
Ongoing Class II Medical devices
- Recall started
- 27 February 2025
- Reason
- The "Use with plate 7, 8, 9, 10" compatibility statement on top of the label does not match with the compatibility statements "USE WITH PLATE 5, 6" in the translations section of the same label.
- Distribution
- Worldwide - US Nationwide distribution in the states pf CA, KS, MA, MD, ME, NE, NJ, OR, SD, and TX. The countries of Canada, China, India, Netherlands, Singapore.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1433-2025
- NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis, Model Number 00-5962-042-10
Ongoing Class II Medical devices
- Recall started
- 12 February 2025
- Reason
- There is a potential design issue with the Z1 Offset Stem Inserter leading to fracturing of the distal tip.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1329-2025
- Z1 Femoral Hip System, Product Number 611777612
Ongoing Class II Medical devices
- Recall started
- 6 January 2025
- Reason
- It was identified internally that two commingle events occurred where the metal support post within the polyethylene articular surface was assembled incorrectly for three units within the scope.
- Distribution
- Worldwide - US Nationwide distribution in the states of CA, FL, GA, KS, MO, NE, NJ, PA, TN and the countries of CHINA, INDIA, KOREA, MALAYSIA, NETHERLANDS, SINGAPORE, TAIWAN.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1039-2025, Z-1038-2025
- NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Yellow/E,F - Height 10 mm, Item Number 00-5994-032-10
- NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C,D - Height 14 mm, Item Number 00-5994-022-14
Ongoing Class II Medical devices
- Recall started
- 17 September 2024
- Reason
- A Gen 5 tail piece was assembled to a Gen 4 Finished Device, resulting in a 0.178" difference in the end of the endoscope slot to the end of the tail piece. This allows the scope to move further into the plastic sheath that runs the length of the device, resulting in an interference fit at the cone, may caus an extension in surgery
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0285-2025
- Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use in minimally invasive surgery allowing access for vessel harvesting and is primarily indicated for patients undergoing endoscopic surgery for arteri
Ongoing Class II Medical devices
- Recall started
- 8 August 2024
- Reason
- Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck sleeve, however, the product within the box is a -6mm neck sleeve, and vice versa. The neck of the sleeve can be identified by the device etching as either STD or -6
- Distribution
- Worldwide distribution - US Nationwide and the countries of Japan, Netherlands.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3133-2024, Z-3132-2024
- Biolox Option Taper Sleeve, Type 1 Taper, -6mm Neck - Indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components. Item Number: 650-1064
- Biolox Option Taper Sleeve, Type 1 Taper, Standard Neck - Indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components. Item Number: 650-1066
Ongoing Class II Medical devices
- Recall started
- 2 July 2024
- Reason
- Affected product has an increased risk of postoperative perisprosthetic femoral fracture (PFF). The IFU is being updated to reflect the risk of PFF.
- Distribution
- Worldwide - US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2450-2024
- CPT Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis, used in Hip Arthroplasty; Item Numbers 00811400000 00811400010 00811400100 00811400110 00811400200 00811400210 00811400218 00811400230 00811400300
Ongoing Class II Medical devices
- Recall started
- 28 March 2024
- Reason
- Out of specification violation of devices that results in a gap existing within the fixture that presses the fiber metal pad to the substrate, causing the pad to not fully bond to the substrate.
- Distribution
- Worldwide distribution - US Nationwide including the states of AK, AL, CA, FL, GA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, NH, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI and the countries of Australia, Canada, Japan, Netherlands.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1608-2024
- NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the NexGen CR-Flex Porous Femur System.
Ongoing Class II Medical devices
- Recall started
- 20 March 2024
- Reason
- Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in surgery or loss of fixation resulting further intervention
- Distribution
- Worldwide distribution - US Nationwide and the countries of Brazil, Canada, China, Hong Kong, India, Japan, New Zealand, Seoul Korea, Singapore, Switzerland, Taiwan.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1716-2024, Z-1723-2024, Z-1721-2024, Z-1720-2024, Z-1710-2024, Z-1724-2024, Z-1727-2024, Z-1717-2024, Z-1713-2024, Z-1709-2024, Z-1726-2024, Z-1719-2024 and 9 more
- ZPLP(Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 6 Holes, 106 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-235
- ZPLP Distal Lateral Fibular Plate, Right, 6 Holes, 106 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 00-2357-017-06
- ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 16 Holes, 236 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-23
- ZPLP Distal Lateral Fibular Plate, Left, 14 Holes, 210 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-018-14
- ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 6 Holes, 106 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2
- ZPLP Distal Lateral Fibular Plate, Right, 8 Holes, 132 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 00-2357-017-08
- ZPLP Distal Lateral Fibular Plate, Left, 6 Holes, 106 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 00-2357-018-06
- ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 8 Holes, 132 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-235
- and 13 more product lines
Ongoing Class II Medical devices
- Recall started
- 26 July 2023
- Reason
- The outer package labeling and product etch are for a Size 6, however, the implant is a Size 4, and vice versa.
- Distribution
- Worldwide - US Nationwide distribution in the states of AL, CA, GA, MI, NJ, PA, TN, and WI. The countries of Brazil, Canada, Netherlands.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2519-2023
- M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item Number 00771100640) and Size 6 (Item Number 00771100440)
Ongoing Class II Medical devices
- Recall started
- 27 June 2023
- Reason
- Thread form issue of the locking holes in that the locking screws would not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock.
- Distribution
- AR AZ MA ME MO NJ NM NY OR WA Foreign: Brazil China Dominican Republic Korea Netherlamds Taiwan
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2254-2023
- Zimmer Periarticular Locking Plate (ZPLP) Distal Lateral Femoral Plate 6 holes 159 mm Length-Indicated for temporary internal fixation and stabilization of osteotomies and fractures, including comminuted fractures, supra
Terminated Class II Medical devices
- Recall started
- 19 May 2023
- Terminated
- 29 May 2026
- Reason
- Device outer packaging was incorrectly labeled.
- Distribution
- International distribution in the country of India.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2092-2023
- NexGen Precoat Stemmed Tibial Plate Size 5
Ongoing Class II Medical devices
- Recall started
- 27 February 2023
- Reason
- Update the compatibility matrix as referred to in the Instructions for Use (IFU) for the CoCr Femoral Head XS- removes the compatibility with the Epsilon Durasul Constrained Acetabular Liners from the matrix due to the range of motion in flexion/extension being less than 100 degrees as recommended per an internationally recognized standard (ISO 21535:2009
- Distribution
- AL AZ CO FL LA MI OH OK TX Foreign: Canada
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1294-2023
- CoCr Femoral Head, XS, 38/-8, Taper 12/14-Intended to be used as a modular head component for articulation in total hip arthroplasty. Item Number: 01.01012.384
Ongoing Class II Medical devices
- Recall started
- 7 December 2022
- Reason
- Two planers were found to be unusable during sawbones shoulder training.
- Distribution
- US Nationwide distribution in the states of AR, CA, IL, MI, NJ, NY, OK, PA, TX, and WA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1098-2023
- Identity Shoulder System Resection Planer 35mm Resection Planer
Ongoing Class II Medical devices
- Recall started
- 6 December 2022
- Reason
- Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial components are used with either the Legacy Posterior Stabilized (LPS) Flex or LPS Flex Gender Solutions Femoral (GSF) components as compared to other total knee arthroplasties in the United Kingdom National Joint Registry (UK NJR). Removing the NexGen Stemmed Option Tibial Component f rom inventory will prevent its future implantation with either the LPS Flex or LPS Flex GSF femoral components and mitigate the increased revision risk with these two specific combinations of tibial and femoral component.
- Distribution
- Worldwide - US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0470-2023, Z-0468-2023, Z-0467-2023, Z-0469-2023, Z-0471-2023, Z-0466-2023
- NexGen Option Stemmed Tibial Component Size 7, Item Number 00-5986-057-01
- NexGen Option Stemmed Tibial Component Size 5, Item Number 00-5986-047-01
- NexGen Option Stemmed Tibial Component Size 4, Item Number 00-5986-037-02
- NexGen Option Stemmed Tibial Component Size 6, Item Number 00-5986-047-02
- NexGen Option Stemmed Tibial Component Size 8, Item Number 00-5986-057-02
- NexGen Option Stemmed Tibial Component Size 3, Item Number 00-5986-037-01
Ongoing Class II Medical devices
- Recall started
- 25 August 2022
- Reason
- The outer sterile package cavity has a corner wall thickness that is below the specification. The thin corner wall could potentially crack during transit. Potential risks include non-clinically or clinically significant extension of surgery, or infection leading to surgical intervention.
- Distribution
- Domestic distribution US nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0007-2023
- G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E), 010000667 (60 MM G). used in hip arthroplasty
Terminated Class II Medical devices
- Recall started
- 7 May 2021
- Terminated
- 18 April 2024
- Reason
- Zimmer Natural Nail (ZNN) System-CMN Femoral Nail potential commingle between CCD angle 130 degree and 125 degree
- Distribution
- CA, GA, KY, MD Foreign: Australia Brazil, Canada Netherlands
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1792-2021, Z-1793-2021
- Zimmer Natural Nail -ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 125 CCD Left Ti-6Al-4V Alloy- intended for temporary fracture fixation and stabilization of the bone Item Number: 47-2493-211-11
- Zimmer Natural Nail- ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 130 CCD Left Ti-6Al-4V Alloy-is intended for temporary fracture fixation and stabilization of the bone Item Number: 47-2493-213-11
Terminated Class II Medical devices
- Recall started
- 21 August 2019
- Terminated
- 20 July 2020
- Reason
- Incorrect labeling on the products package. The label on the package shows size 50-18 whereas the implant inside the packaging size 40-14.
- Distribution
- Worldwide distribution - iUS Nationwide distribution including states of AL, CO, KS, NJ, NY, OH, and OK, and countries of Belgium, Czech Republic, France, Germany, Switzerland, and United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2762-2019
- Sidus Stem-Free Shoulder Humeral Head 50-18 Item number: 01.04555.500 orthopedic implant - Product Usage: The Sidus Stem-Free Shoulder is designed for long-term implantation into the human shoulder joint as a total shou
Terminated Class II Medical devices
- Recall started
- 8 April 2019
- Terminated
- 11 May 2020
- Reason
- An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
- Distribution
- The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1448-2019, Z-1486-2019, Z-1482-2019, Z-1455-2019, Z-1415-2019, Z-1439-2019, Z-1472-2019, Z-1442-2019, Z-1449-2019, Z-1443-2019, Z-1458-2019, Z-1480-2019 and 64 more
- V-TEK", IVP step drill 2.5-3.9x124mm, 16mm stop, contra-angle, Item Number 502015637
- Drill, contra-angle, 1.5x85mm, Item Number ST502015706
- Drill, cannulated, 3x90mm, AO, Item Number ST502015631
- CBS micro, countersink, cannulated, round-shaft, Item Number 503004341
- Drill, 15mm stop, 1x83mm, Stryker, Item Number 502015114
- Drill, cannulated, 2.5x95mm, AO, Item Number 502015621
- Drill for 3.5mm screw, 2.5x120mm, AO, Item Number ST502015216
- Drill, cannulated, 2.8x150mm, AO, Item Number 502015629
- and 68 more product lines
Terminated Class II Medical devices
- Recall started
- 31 October 2018
- Terminated
- 1 April 2020
- Reason
- Mislabeled Labeled Avenir M¿ller Stem size 1, the stem inside the packaging is an Avenir M¿ller Stem size 2 .
- Distribution
- International distribution in the countries of Germany and Switzerland.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0644-2019
- Avenir¿ Muller Stem Standard, uncemented HA, 1, Taper 12/14 Item Number: 01.06010.001 - Product Usage: Avenir@ Muller Stems are intended to reduce pain and increase hip mobility through long term cementless fixation of t
Terminated Class II Medical devices
- Recall started
- 15 March 2018
- Terminated
- 25 April 2019
- Reason
- Product may contain a gap between the handle and metal chisel which can lead to failure to properly disinfect or sterilize between use.
- Distribution
- CO, IN, TX, IL
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1360-2018
- Normed Charcot Osteotome Chisel (Various sizes)
Terminated Class II Medical devices
- Recall started
- 28 February 2018
- Terminated
- 25 October 2019
- Reason
- A potential commingle that could result in the product in the package not matching the product on the outer label.
- Distribution
- There was no distribution to the US. The distribution occurred to the following countries: Belgium, Switzerland, Germany, France, Canary Islands, Italy, and Thailand.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1525-2018, Z-1524-2018
- Avenir Muller Stem; Item Number: 01.06010.104, Lot Number: 2905496, UDI: (01)00889024479500 (17)220430 (10)2905496
- Avenir Muller Stem; Item Number: 01.06010.003, Lot Number: 2904368, UDI: (01) 00889024479494 (17) 220331 (10) 2904368
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.