Intramedullary Bone Saw Blade Assembly
Biomet recalls Intramedullary Bone Saw Blade Assembly (Model 475620) over sterile barrier damage risk.
Do not use the affected Intramedullary Bone Saw Blade Assembly. Contact Biomet, Inc. for instructions on returning the device and obtaining a replacement.
Why it was recalled
Biomet, Inc. is recalling the Intramedullary Bone Saw Blade Assembly, Model/Catalog Number 475620, due to potential sterile barrier packaging damage caused by an exposed saw blade. This may compromise the sterility of the device.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
Intramedullary Bone Saw Blade Assembly Model/Catalog Number
| Product | Lot code | Recall # | UDI-DI |
|---|---|---|---|
| 475625 Product Description: Intramedullary Bone Saw Blade Assembly 13mm | 67818772 | Z-2868-2026 | 00887868507809, 67818772, 67818772 |
| 475635 Product Description: Intramedullary Bone Saw Blade Assembly 15mm | 67818769, 475635, 67818770 | Z-2870-2026 | 00887868507823, 67818769, 67818769, 00887868507823, 67818770, 67818770 |
| 475620 Product Description: Intramedullary Bone Saw Blade Assembly 12mm | 67818791 | Z-2867-2026 | 00887868507793, 67818791, 67818791 |
| 475640 Product Description: Intramedullary Bone Saw Blade Assembly 16mm | 67818792 | Z-2871-2026 | 00887868507830, 67818792, 67818792 |
| 475630 Product Description: Intramedullary Bone Saw Blade Assembly 14mm | 67818764, 475630, 67818768, 67954534 | Z-2869-2026 | 00887868507816, 67818764, 67818764, 00887868507816, 67818768, 67818768, 00887868507816, 67954534, 67954534 |
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Sterility Failure recalls
Editorial summary by Recall Canary · summary updated 2026-09-03 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification