Biomet bone saw blade assembly recalled for sterile packaging risk
Zimmer Biomet is removing various sizes of the Intramedullary Bone Saw Blade Assembly from distribution. The recall is for potential damage to the sterile barrier packaging, which could be caused by an exposed saw blade. The notice reports no injuries, and 11 units are affected.
From the FDA notice · Read the official notice ↗
What to do
- Set aside any affected units, including model 475640 (16mm) from lot 67818792 (UDI-DI 00887868507830), and do not use them.
- The notice does not specify a remedy. Contact Zimmer Biomet for return and replacement instructions.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475640 Product Description: Intramedullary Bone Saw Blade Assembly 16mm
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
This recall covers 5 products — see all of them.
Details
- Units affected
- 11
- Illnesses reported
- None reported
- Manufactured in
- 56 E Bell Dr, Warsaw, IN, United States
- Classification
- Class II
- Recall number
- Z-2871-2026
In the FDA's words
- Description
- 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. UDI-DI (01)00887868507830(17)360316(10)67818792; Lot 67818792 Distribution: 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. Affected quantity: 11
- Hazard
- 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.
5 products in this recall
The agency lists each product separately. Check every one you might have.
- Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475620 Product Description: Intramedullary Bone Saw Blade Assembly 12mmZ-2867-2026 · 10
- Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475625 Product Description: Intramedullary Bone Saw Blade Assembly 13mmZ-2868-2026 · 12
- Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475630 Product Description: Intramedullary Bone Saw Blade Assembly 14mmZ-2869-2026 · 26
- Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475635 Product Description: Intramedullary Bone Saw Blade Assembly 15mmZ-2870-2026 · 22
- Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475640 Product Description: Intramedullary Bone Saw Blade Assembly 16mm (this page)Z-2871-2026 · 11