Zimmer
FDA adverse event reports naming Zimmer as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: ZIMMER.
- Total reports
- 2,505
- Deaths
- 16
- Injuries
- 1,638
- Malfunctions
- 777
Reports per year
Source: FDA adverse event reports by year received, 2010–2025. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerJWH739
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedLPH412
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, CementedJDI207
- Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedKWY160
- Prosthesis, Knee, Hemi-, Patellar Resurfacing, UncementedHTG134
- Screw, Fixation, BoneHWC94
- Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or UncementedMRA69
- Prosthesis, Hip, Hemi-, Acetabular, Cemented, MetalKWB64
- Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)HSH55
- Rod, Fixation, Intramedullary And AccessoriesHSB47
Recent recalls
- 2026-07-02Open, ClassifiedUnder Investigation by firm
Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S 4000 TS Tourniquet Systems Dual Hose with CPC Connectors Model/Catalog Number: 60-1812-101-00 Software Version: N/A Product Description: Dual Sterile Extension Hose with PLC Connector Component: N/A
Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find another readily available device.
- 2026-07-02Open, ClassifiedUnder Investigation by firm
Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S 4000 TS Tourniquet Systems Single Hose with CPC Connectors Model/Catalog Number: 60-4009-101-00 Software Version: N/A Product Description: Single Sterile Extension Hose with PLC Connector Component: N/A
Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find another readily available device.
- 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.
- 2026-01-28Open, ClassifiedUnder Investigation by firm
Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S. 5000TS Tourniquet Systems Model/Catalog Number: 60500010100 Software Version: Software version v2.04 or prior are within scope of the recall for A.T.S. 5000TS Product Description: A.T.S 5000TS Tourniquet Systems Component: N/A
Device user interface (screen) may freeze or become unresponsive to touch when operating in certain non-English language settings. Issue may cause delay or extension while alternate device is located.
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