Smith & Nephew Orthopaedics Ag
FDA adverse event reports naming Smith & Nephew Orthopaedics Ag as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: SMITH & NEPHEW ORTHOPAEDICS AG.
- Total reports
- 2,468
- Deaths
- 4
- Injuries
- 1,837
- Malfunctions
- 627
Reports per year
Source: FDA adverse event reports by year received, 2010–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedLZO715
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedLPH351
- Orthopedic Manual Surgical InstrumentLXH300
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, CementedJDI172
- Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedKWY158
- Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerJWH153
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, UncementedLWJ139
- Prosthesis, Hip, Hemi-, Trunnion-Bearing, Femoral, Metal/PolyacetalJDH127
- Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/PolymerKRO100
- Prosthesis, Hip, Femoral Component, Cemented, MetalJDG57
Recent recalls
- Open, ClassifiedDevice Design
POLARSTEM COLLAR Reamer Guide, Catalog Number: 75102205, UPC Codes: 00885556535493 - Product Usage: Once the appropriate trial rasp size is in place, the adapter is removed and the calcar reamer guide (75102205) is positioned on the rasp. The calcar reamer (75102207 or 75102208) is placed over the reamer guide and the femoral neck is machined until the reamer reach the physical stop-fully seated on the inner reamer guide.
Multiple lots being recalled due to a product design issue
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