Manufacturer

Zimmer, Inc.

65 recalls in our database name Zimmer, Inc. as the manufacturing or recalling firm.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 65

ModerateFDA (Devices)·Z-1946-2026·2026-05-06
Disposable Mixing Bowls with Spatula recalled for compromised sterile barrier
Zimmer, Inc. is recalling Disposable Mixing Bowls with Spatula (Model 00-5049-011-00) due to package seal defects that may compromise the sterile barrier. Ten complaints have been received identifying incomplete seals, wrinkles, or peeling seals.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0968-2026·2025-12-31
Affixus Femoral Nails Recalled for Potential Implant Fatigue Fracture Risk
Zimmer is recalling Affixus Antegrade Femoral Nails with undersized distal diameter risking implant fatigue fracture. Affected implants distributed across 14 US states could cause adverse tissue reactions, non-union, or require surgical intervention.
Product
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, Trochanteric Nail Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0980-2026·2025-12-31
Affixus Antegrade Femoral Nails: Potential fatigue fracture due to undersized distal diameter
Zimmer, Inc. is recalling specific lots of Affixus Antegrade Femoral Nails due to potential undersized distal diameter that could cause implant fatigue fracture. No injuries have been reported.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609420 Software Version: N/A Product Description: Affixus 9 mm, Length 420 mm, Left, Trochanteric Nail Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0976-2026·2025-12-31
Femoral Nails Recalled for Risk of Implant Fatigue Fracture
Zimmer, Inc. is recalling Affixus Antegrade Femoral Nails due to undersized distal diameters that could cause implant fatigue fracture. The defect may lead to non-union, malunion, or tissue damage requiring surgical intervention.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609340 Software Version: N/A Product Description: Affixus 9 mm, Length 340 mm, Left, Trochanteric Nail Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0979-2026·2025-12-31
Zimmer Affixus Antegrade Femoral Nails Recalled for Fatigue Fracture Risk
Zimmer is recalling 24 units of Affixus Antegrade Femoral Nails due to a manufacturing defect that could cause implant fracture. Patients who received these units should contact their healthcare provider.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609400 Software Version: N/A Product Description: Affixus 9 mm, Length 400 mm, Left, Trochanteric Nail Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0981-2026·2025-12-31
Affixus Femoral Nails Recalled for Potential Implant Fatigue Fracture
Zimmer, Inc. is recalling Affixus Antegrade Femoral Nailing System implants with undersized distal diameter that could fracture during use, potentially requiring surgical intervention.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609440 Software Version: N/A Product Description: Affixus 9 mm, Length 440 mm, Left, Trochanteric Nail Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0970-2026·2025-12-31
Affixus Femoral Nails recalled for potential implant fatigue fracture
Zimmer is recalling Affixus Antegrade Femoral Nails due to undersized distal diameter that could cause implant fatigue fracture and require surgery.
Product
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, Trochanteric Nail Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0974-2026·2025-12-31
Affixus Antegrade Femoral Nails Recalled for Potential Implant Fracture
Zimmer is recalling 11 Affixus Antegrade Femoral Nails due to potential undersized distal diameters that may cause implant fatigue fracture. Complications can include adverse tissue reaction, pain, non-union, or tissue damage requiring surgery.
Product
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, Trochanteric Nail Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0969-2026·2025-12-31
Affixus Antegrade Femoral Nailing System Recalled for Implant Fracture Risk
Zimmer is recalling specific lots of Affixus Antegrade Femoral Nails due to undersized distal diameter that could cause implant fracture. Affected patients may experience tissue damage or adverse reactions requiring additional surgery.
Product
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, Trochanteric Nail Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0971-2026·2025-12-31
Orthopedic nail implants recalled due to potential fatigue fracture risk
Zimmer is recalling Affixus Antegrade Femoral Nailing System implants that may have undersized distal diameter, creating risk of implant fatigue fracture and potential need for surgical intervention.
Product
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, Trochanteric Nail Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0977-2026·2025-12-31
Zimmer Affixus Femoral Nails Risk of Fatigue Fracture
Zimmer is recalling Affixus Antegrade Femoral Nails due to undersized distal diameter that could cause implant fatigue fracture. Affected patients may experience pain, non-union, tissue damage, and may require surgical intervention.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609360 Software Version: N/A Product Description: Affixus 9 mm, Length 360 mm, Left, Trochanteric Nail Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0983-2026·2025-12-31
Zimmer Affixus Femoral Nails Recalled for Fatigue Fracture Risk
Zimmer Affixus Antegrade Femoral Nails may develop undersized defects leading to implant fatigue fracture, potentially causing pain, tissue damage, and the need for revision surgery. The FDA Class II recall affects 11 units distributed nationwide.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509300 Software Version: N/A Product Description: Affixus 9 mm, Length 300 mm, Right, Trochanteric Nail Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0982-2026·2025-12-31
Affixus Antegrade Femoral Nails Recalled for Undersized Distal Diameter
Zimmer is recalling limited units of Affixus Antegrade Femoral Nails due to undersized distal diameter that may cause implant fracture. Potential complications include non-union, malunion, and tissue damage requiring surgical intervention.
Product
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 Nail Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0967-2026·2025-12-31
Zimmer Affixus Femoral Nails Recalled for Potential Fatigue Fracture Risk
Zimmer, Inc. is recalling 22 Affixus Antegrade Femoral Nailing systems due to an undersized distal diameter defect that could cause implant fatigue fracture. Potential complications include tissue damage and surgical intervention may be required.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509320 Software Version: N/A Product Description: Affixus 9 mm, Length 320 mm, Right, Trochanteric Nail Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0975-2026·2025-12-31
Zimmer Affixus Femoral Nails recalled for potential implant fracture risk
Zimmer is recalling Affixus Antegrade Femoral Nails due to undersized distal diameter that could cause implant fracture, potentially leading to tissue damage requiring surgery. The recall affects 23 units distributed nationwide.
Product
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, Trochanteric Nail Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0972-2026·2025-12-31
Affixus Femoral Nails recalled for undersized shaft fracture risk
Zimmer is recalling Affixus Antegrade Femoral Nails (Model 815509420) due to undersized shaft diameter that may cause implant fracture, potentially requiring additional surgery.
Product
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, Trochanteric Nail Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0973-2026·2025-12-31
Zimmer Affixus Femoral Nails Recalled for Undersized Components
Zimmer is recalling 22 Affixus Antegrade Femoral Nails due to undersized distal diameters that may cause implant fracture and complications including pain and tissue damage requiring surgery.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509440 Software Version: N/A Product Description: Affixus 9 mm, Length 440 mm, Right, Trochanteric Nail Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0978-2026·2025-12-31
Femoral Nailing System Implants Recalled for Undersized Distal Diameter Risk
Zimmer's Affixus femoral nails may have undersized distal diameters risking implant fracture. Affected patients may experience pain, failed bone healing, or require additional surgery.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609380 Software Version: N/A Product Description: Affixus 9 mm, Length 380 mm, Left, Trochanteric Nail Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0418-2026·2025-11-12
Zimmer Hip Implant Bearing Recalled for Package-Size Mismatch
Zimmer, Inc. is recalling 72 units of Dual Mobility Vivacit-E hip implant bearings due to a commingle where packages labeled Size F 44 mm contain Size G 46 mm implants, and vice versa.
Product
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
Category
Medical Device
Distribution
20 states
HighFDA (Devices)·Z-0419-2026·2025-11-12
Zimmer Biomet Hip Prosthesis Bearing Recalled for Packaging Size Mismatch
Zimmer Inc. is recalling 63 units of the Dual Mobility Vivacit-E bearing due to a packaging commingle where Size G implants are in Size F packages and vice versa. The wrong-sized implant could cause serious complications if implanted.
Product
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
Category
Medical Device
Distribution
20 states
HighFDA (Devices)·Z-1649-2025·2025-04-30
Zimmer Biomet Hip Prosthesis Ceramic Head Lacks Stem Compatibility Labeling
Zimmer Biomet Ceramic Hip Prosthesis heads lack adequate labeling information for compatibility with certain femoral stems. This labeling deficiency affects 160 units distributed worldwide.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1645-2025·2025-04-30
Zimmer Biomet Ceramic Hip Head Recall — Missing Compatibility Labeling
Zimmer, Inc. is recalling the Zimmer Biomet Ceramic Hip Head (Model 802602202) due to inadequate labeling of compatibility information for use with cobalt-chrome or stainless-steel femoral stems.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1648-2025·2025-04-30
Zimmer Biomet Ceramic Hip Prosthesis Head Lacks Stem Compatibility Labeling
Zimmer Biomet's ceramic hip prosthesis head (Model 802802202) lacks adequate labeling for compatibility with certain femoral stems, risking improper surgical assembly.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1647-2025·2025-04-30
Zimmer Biomet Hip Prosthesis Ceramic Head Lacks Compatibility Information
Zimmer, Inc. is recalling ceramic hip prosthesis heads (22.2 mm diameter) because product labeling does not adequately specify compatibility with cobalt-chrome or stainless-steel femoral stems.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1646-2025·2025-04-30
Zimmer Biomet Ceramic Head Hip Prosthesis Lacks Compatibility Information
Zimmer Biomet is recalling a ceramic hip prosthesis component due to inadequate labeling that does not specify compatibility with certain femoral stems. The missing compatibility information could lead to improper use during surgical implantation.
Product
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
Category
Medical Device
Distribution
Distributed nationwide