Zimmer Biomet bone saw blade recalled for potential packaging damage
Zimmer Biomet is recalling 22 Intramedullary Bone Saw Blade Assemblies (model 475635, 15mm). 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 affected units from lots 67818769 and 67818770 (model 475635) and do not use them.
- Identify affected units by UDI-DI 00887868507823 and the lot numbers listed in the notice.
- The notice doesn't 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: 475635 Product Description: Intramedullary Bone Saw Blade Assembly 15mm
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
This recall covers 5 products — see all of them.
Details
- Units affected
- 22
- Illnesses reported
- None reported
- Manufactured in
- 56 E Bell Dr, Warsaw, IN, United States
- Classification
- Class II
- Recall number
- Z-2870-2026
In the FDA's words
- Description
- Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475635 Product Description: Intramedullary Bone Saw Blade Assembly 15mm 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)00887868507823(17)360224(10)67818769; Lot 67818769 Model No 475635; UDI-DI (01)00887868507823(17)360225(10)67818770; Lot 67818770 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: 22
- 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 15mm (this page)Z-2870-2026 · 22
- Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475640 Product Description: Intramedullary Bone Saw Blade Assembly 16mmZ-2871-2026 · 11