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Zimmer, Inc. FDA Recalls
71 recalls on file across devices, 0 of them Class I and 70 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
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| Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241Class IIMay 20, 2026Five complaints have been received identifying issues where |
| Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040476Class IIMay 20, 2026Five complaints have been received identifying issues where |
| Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040444Class IIMay 20, 2026Five complaints have been received identifying issues where |
| Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040242Class IIMay 20, 2026Five complaints have been received identifying issues where |
| Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240Class IIMay 20, 2026Five complaints have been received identifying issues where |
| Brand Name: Persona Revision Product Name: Persona Revision¿ Trabecular Metal¿ Femoral Distal Augment Model/Catalog NuClass IIMay 11, 2026Firm received a complaint with no clinical impact in which a |
| Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and Spatula Model/Catalog Number: 00-5049-0Class IIMar 30, 2026Ten complaints have been received identifying issues at the |
| Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:Class IIDec 2, 2025Affected implants may have undersized distal diameter along |
| Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:Class IIDec 2, 2025Affected implants may have undersized distal diameter along |
| Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:Class IIDec 2, 2025Affected implants may have undersized distal diameter along |
| Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:Class IIDec 2, 2025Affected implants may have undersized distal diameter along |
| Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:Class IIDec 2, 2025Affected implants may have undersized distal diameter along |
| Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:Class IIDec 2, 2025Affected implants may have undersized distal diameter along |
| Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:Class IIDec 2, 2025Affected implants may have undersized distal diameter along |
| Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:Class IIDec 2, 2025Affected implants may have undersized distal diameter along |
| Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:Class IIDec 2, 2025Affected implants may have undersized distal diameter along |
| Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:Class IIDec 2, 2025Affected implants may have undersized distal diameter along |
| Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:Class IIDec 2, 2025Affected implants may have undersized distal diameter along |
| Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:Class IIDec 2, 2025Affected implants may have undersized distal diameter along |
| Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:Class IIDec 2, 2025Affected implants may have undersized distal diameter along |
| Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:Class IIDec 2, 2025Affected implants may have undersized distal diameter along |
| Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:Class IIDec 2, 2025Affected implants may have undersized distal diameter along |
| Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:Class IIDec 2, 2025Affected implants may have undersized distal diameter along |
| Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:Class IIDec 2, 2025Affected implants may have undersized distal diameter along |
| Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 46 mm O.D., Size G, Bearing, Model/CaClass IISep 26, 2025Zimmer Biomet is conducting a medical device recall for two |
| Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 44 mm O.D., Size F, Bearing, Model/CaClass IISep 26, 2025Zimmer Biomet is conducting a medical device recall for two |
| Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +3 Neck, Model Number 802602203; Prosthesis, Hip, Semi-ConstrClass IIMar 24, 2025The associated product labeling does not adequately provide |
| Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +0 Neck, Model Number 802602202; Prosthesis, Hip, Semi-ConstrClass IIMar 24, 2025The associated product labeling does not adequately provide |
| Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +3 Neck, Model Number 802802203; Prosthesis, Hip, Semi-ConstrainedClass IIMar 24, 2025The associated product labeling does not adequately provide |
| Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +0 Neck, Model Number 802802202; Prosthesis, Hip, Semi-ConstrainedClass IIMar 24, 2025The associated product labeling does not adequately provide |
| Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, -3 Neck, Model Number 802802201; Prosthesis, Hip, Semi-ConstrainedClass IIMar 24, 2025The associated product labeling does not adequately provide |
| NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis, Model NumberClass IIFeb 27, 2025The "Use with plate 7, 8, 9, 10" compatibility statement on |
| Z1 Femoral Hip System, Product Number 611777612Class IIFeb 12, 2025There is a potential design issue with the Z1 Offset Stem In |
| NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C,D - Height 14 mm, Item Number 00-5994-022-14Class IIJan 6, 2025It was identified internally that two commingle events occur |
| NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Yellow/E,F - Height 10 mm, Item Number 00-5994-032-10Class IIJan 6, 2025It was identified internally that two commingle events occur |
| Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use in minimally invasive surgery allowing access foClass IISep 17, 2024A Gen 5 tail piece was assembled to a Gen 4 Finished Device, |
| CPT Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis, used in Hip Arthroplasty; Item Numbers 00811400000 00Class IIJul 2, 2024Affected product has an increased risk of postoperative peri |
| NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the NexGen CR-Flex Porous Femur System.Class IIMar 28, 2024Out of specification violation of devices that results in a |
| ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 10 Holes, 158 MM, Sterile- IndicatClass IIMar 20, 2024Thread form issue for the locking holes in that the locking |
| ZPLP(Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 10 Holes, 158 MM, Sterile- IndicateClass IIMar 20, 2024Thread form issue for the locking holes in that the locking |
| ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 16 Holes, 236 MM, Sterile- IndicateClass IIMar 20, 2024Thread form issue for the locking holes in that the locking |
| ZPLP Distal Lateral Fibular Plate, Left, 14 Holes, 210 MM, Sterile- Indicated for temporary internal fixation and stabilClass IIMar 20, 2024Thread form issue for the locking holes in that the locking |
| ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 6 Holes, 106 MM, Sterile- IndicatClass IIMar 20, 2024Thread form issue for the locking holes in that the locking |
| ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 4 Holes, 80 MM, Nonsterile- IndicClass IIMar 20, 2024Thread form issue for the locking holes in that the locking |
| ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 8 Holes, 132 MM, Sterile- IndicateClass IIMar 20, 2024Thread form issue for the locking holes in that the locking |
| ZPLP Distal Lateral Fibular Plate, Right, 10 Holes, 158 MM, Nonsterile- Indicated for temporary internal fixation and stClass IIMar 20, 2024Thread form issue for the locking holes in that the locking |
| ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 8 Holes, 132 MM, Sterile- IndicatedClass IIMar 20, 2024Thread form issue for the locking holes in that the locking |
| ZPLP(Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 6 Holes, 106 MM, Sterile- IndicatedClass IIMar 20, 2024Thread form issue for the locking holes in that the locking |
| ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 16 Holes, 236 MM, Sterile- IndicatClass IIMar 20, 2024Thread form issue for the locking holes in that the locking |
| ZPLP Distal Lateral Fibular Plate, Right, 8 Holes, 132 MM, Nonsterile- Indicated for temporary internal fixation and staClass IIMar 20, 2024Thread form issue for the locking holes in that the locking |
| ZPLP Distal Lateral Fibular Plate, Left, 4 Holes, 80 MM, Nonsterile- Indicated for temporary internal fixation and stabiClass IIMar 20, 2024Thread form issue for the locking holes in that the locking |
| ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 4 Holes, 80 MM, Sterile- IndicatedClass IIMar 20, 2024Thread form issue for the locking holes in that the locking |
| ZPLP Distal Lateral Fibular Plate, Left, 6 Holes, 106 MM, Nonsterile- Indicated for temporary internal fixation and stabClass IIMar 20, 2024Thread form issue for the locking holes in that the locking |
| ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 12 Holes, 184 MM, Sterile- IndicatClass IIMar 20, 2024Thread form issue for the locking holes in that the locking |
| ZPLP Distal Lateral Fibular Plate, Right, 6 Holes, 106 MM, Nonsterile- Indicated for temporary internal fixation and staClass IIMar 20, 2024Thread form issue for the locking holes in that the locking |
| ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 12 Holes, 184 MM, Sterile- IndicatClass IIMar 20, 2024Thread form issue for the locking holes in that the locking |
| ZPLP Distal Lateral Fibular Plate, Left, 4 Holes, 80 MM, Sterile- Indicated for temporary internal fixation and stabilizClass IIMar 20, 2024Thread form issue for the locking holes in that the locking |
| ZPLP Distal Lateral Fibular Plate, Left, 8 Holes, 132 MM, Nonsterile-Indicated for temporary internal fixation and stabiClass IIMar 20, 2024Thread form issue for the locking holes in that the locking |
| ZPLP Distal Lateral Fibular Plate, Left, 10 Holes, 158 MM, Nonsterile-Indicated for temporary internal fixation and stabClass IIMar 20, 2024Thread form issue for the locking holes in that the locking |
| M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item Number 00771100640) and Size 6 (Item Number Class IIJul 26, 2023The outer package labeling and product etch are for a Size 6 |
| Zimmer Periarticular Locking Plate (ZPLP) Distal Lateral Femoral Plate 6 holes 159 mm Length-Indicated for temporary intClass IIJun 27, 2023Thread form issue of the locking holes in that the locking s |
| NexGen Precoat Stemmed Tibial Plate Size 5Class IIMay 19, 2023Device outer packaging was incorrectly labeled. |
| CoCr Femoral Head, XS, 38/-8, Taper 12/14-Intended to be used as a modular head component for articulation in total hip Class IIFeb 27, 2023Update the compatibility matrix as referred to in the Instru |
| Identity Shoulder System Resection Planer 35mm Resection PlanerClass IIDec 7, 2022Two planers were found to be unusable during sawbones should |
| NexGen Option Stemmed Tibial Component Size 5, Item Number 00-5986-047-01Class IIDec 6, 2022Zimmer Biomet is conducting a voluntary medical device recal |
| NexGen Option Stemmed Tibial Component Size 6, Item Number 00-5986-047-02Class IIDec 6, 2022Zimmer Biomet is conducting a voluntary medical device recal |
| NexGen Option Stemmed Tibial Component Size 8, Item Number 00-5986-057-02Class IIDec 6, 2022Zimmer Biomet is conducting a voluntary medical device recal |
| NexGen Option Stemmed Tibial Component Size 7, Item Number 00-5986-057-01Class IIDec 6, 2022Zimmer Biomet is conducting a voluntary medical device recal |
| NexGen Option Stemmed Tibial Component Size 4, Item Number 00-5986-037-02Class IIDec 6, 2022Zimmer Biomet is conducting a voluntary medical device recal |
| NexGen Option Stemmed Tibial Component Size 3, Item Number 00-5986-037-01Class IIDec 6, 2022Zimmer Biomet is conducting a voluntary medical device recal |
| G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E), 010000667 (60 MM G). used in hipClass IIAug 25, 2022The outer sterile package cavity has a corner wall thickness |