Biomet saw blade assemblies recalled for possible packaging damage
Zimmer Biomet is removing certain lots of the 14mm Intramedullary Bone Saw Blade Assembly, Model 475630, because the sterile barrier packaging may be damaged, which could expose the saw blade. No injuries have been reported.
From the FDA notice · Read the official notice ↗
What to do
- Set aside units from the affected lots and do not use them.
- Check the lot numbers 67818764, 67818768 and 67954534 and Model 475630. The UDI-DI on the package is 00887868507816.
- Contact Zimmer Biomet for instructions. The notice does not specify a remedy.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475630 Product Description: Intramedullary Bone Saw Blade Assembly 14mm
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
This recall covers 5 products — see all of them.
Details
- Units affected
- 26
- Illnesses reported
- None reported
- Manufactured in
- 56 E Bell Dr, Warsaw, IN, United States
- Classification
- Class II
- Recall number
- Z-2869-2026
In the FDA's words
- Description
- 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. UDI-DI (01)00887868507816(17)360221(10)67818764; Lot 67818764 Model No 475630; UDI-DI (01)00887868507816(17)360401(10)67818768; Lot 67818768 Model No 475630; UDI-DI (01)00887868507816(17)360428(10)67954534; Lot 67954534 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: 26
- 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 14mm (this page)Z-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