FDA recall, , Moderate risk
Zimmer Biomet Intramedullary Bone Saw Blade Assembly
The Intramedullary Bone Saw Blade Assembly may have damaged sterile barrier packaging due to an exposed saw blade.
Summary by Recall Canary from the FDA notice
What happened
Biomet, Inc. of Warsaw, Indiana, 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. The recall began on July 1, 2026, and was added to the FDA's Enforcement Report on August 3, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
5 products
Match the UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475625 Product Description: Intramedullary Bone Saw Blade Assembly 13mm
- UDI-DI
- 00887868507809
- 67818772
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475635 Product Description: Intramedullary Bone Saw Blade Assembly 15mm
- UDI-DI
- 00887868507823
- 67818769
- 67818770
- Lot code
- 475635
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475620 Product Description: Intramedullary Bone Saw Blade Assembly 12mm
- UDI-DI
- 00887868507793
- 67818791
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475640 Product Description: Intramedullary Bone Saw Blade Assembly 16mm
- UDI-DI
- 00887868507830
- 67818792
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475630 Product Description: Intramedullary Bone Saw Blade Assembly 14mm
- UDI-DI
- 00887868507816
- 67818764
- 67818768
- 67954534
- Lot code
- 475630
Recall details
- Company began the recall
- Sold in
Refer to the attached ZFA 2026-00096_Initial Consignee List and ZFA 2026-00096_Initial Distribution History containing the distribution and the identification of the affected consignees.
- Company
- Biomet, Inc.Warsaw, Indiana
- Hazard
- Sterility problem
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99346
- Recall numbers
- Z-2867-2026 to Z-2871-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
