Biomet bone saw blade recalled for potential sterile packaging damage
Zimmer Biomet is removing an Intramedullary Bone Saw Blade Assembly, 13mm, model 475625, from distribution. The recall is for potential sterile barrier packaging damage caused by an exposed saw blade. No injuries have been reported.
From the FDA notice · Read the official notice ↗
What to do
- Set aside affected units and do not use them.
- Check for UDI-DI (01)00887868507809 and lot 67818772 on the product or packaging.
- The notice does not specify a remedy; contact Zimmer Biomet for instructions on return or replacement.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475625 Product Description: Intramedullary Bone Saw Blade Assembly 13mm
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
This recall covers 5 products — see all of them.
Details
- Units affected
- 12
- Illnesses reported
- None reported
- Manufactured in
- 56 E Bell Dr, Warsaw, IN, United States
- Classification
- Class II
- Recall number
- Z-2868-2026
In the FDA's words
- Description
- 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. UDI-DI (01)00887868507809(17)360228(10)67818772; Lot 67818772 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: 12
- 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 13mm (this page)Z-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 16mmZ-2871-2026 · 11