Orthopedic Manual Surgical Instrument
FDA adverse event reports and recall history for orthopedic manual surgical instrument (product code LXH), from the public MAUDE corpus and the live FDA recall database.
- Total reports
- 81,214
- Deaths
- 55
- Injuries
- 7,525
- Malfunctions
- 73,172
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Recent recalls
- 2026-08-06Open, ClassifiedDevice Design
Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 2mm and 6mm Model/Catalog Number: 9323-5312 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No, N/A
Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.
- 2026-08-05Open, ClassifiedProcess design
Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left and right Model/Catalog Number: 9323-5333 and 9323-5334 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
- 2026-08-05Open, ClassifiedProcess design
Brand Name: U2 Total Knee System Product Name: Femoral valgus offset adaptor, 2mm, 4mm, 6mm, left and Femoral valgus offset adaptor, 2mm, 4mm, 6mm, right Model/Catalog Number: 9323-5335, 9323-5337, 9323-5339 and 9323-5336, 9323-5338, 9323-5340 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
- 2026-08-03Open, ClassifiedUnder Investigation by firm
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475620 Product Description: Intramedullary Bone Saw Blade Assembly 12mm
Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.
- 2026-08-03Open, ClassifiedUnder Investigation by firm
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475625 Product Description: Intramedullary Bone Saw Blade Assembly 13mm
Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.
- 2026-08-03Open, ClassifiedUnder Investigation by firm
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475630 Product Description: Intramedullary Bone Saw Blade Assembly 14mm
Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.
- 2026-08-03Open, ClassifiedUnder Investigation by firm
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475635 Product Description: Intramedullary Bone Saw Blade Assembly 15mm
Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.
- 2026-08-03Open, ClassifiedUnder Investigation by firm
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475640 Product Description: Intramedullary Bone Saw Blade Assembly 16mm
Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.
- 2025-04-17Open, ClassifiedDevice Design
Guide Wire with Ruler Tube 3x800 mm DIA; Catalog number/REF: 2351-3080S;
The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery.
- 2025-04-17Open, ClassifiedDevice Design
Guide Wire with Ruler Tube 3x1000 mm DIA; Catalog number/REF: 2351-3100S;
The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery.
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