Zimmer, Inc.
FDA adverse event reports naming Zimmer, Inc. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: ZIMMER, INC..
- Total reports
- 24,136
- Deaths
- 117
- Injuries
- 17,109
- Malfunctions
- 6,650
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerJWH8,610
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, CementedJDI1,708
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedLPH1,327
- Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)KWA1,051
- Orthopedic Manual Surgical InstrumentLXH979
- Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/PolymerKWZ891
- Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerMBH720
- Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedLZO698
- Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)HSH693
- Prosthesis, Shoulder, Hemi-, Humeral, Metallic UncementedHSD654
Recent recalls
- 2026-06-24Open, ClassifiedLabeling Change Control
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 Femoral Distal Augment Size 9, 9+ 10mm Thicknes Component: N/A
Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package.
- 2026-06-23Open, ClassifiedUnder Investigation by firm
Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
- 2026-06-23Open, ClassifiedUnder Investigation by firm
Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
- 2026-06-23Open, ClassifiedUnder Investigation by firm
Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040242
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
- 2026-06-23Open, ClassifiedUnder Investigation by firm
Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040444
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
- 2026-06-23Open, ClassifiedUnder Investigation by firm
Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040476
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
- 2026-04-24Open, ClassifiedVendor change control
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
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.
- 2025-12-22Open, ClassifiedProcess design
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
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.
- 2025-12-22Open, ClassifiedProcess design
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
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.
- 2025-12-22Open, ClassifiedProcess design
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
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.
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