Moderate riskFDA DeviceClass II

Biomet bone saw blade assembly recalled for sterile packaging risk

Zimmer Biomet is removing certain sizes of its Intramedullary Bone Saw Blade Assembly from use. The recall is due to potential damage to the sterile barrier packaging, which could leave the saw blade exposed. The notice reports no injuries.

From the FDA notice · Read the official notice ↗

What to do

  1. Set aside affected units of model 475620 from lot 67818791 and do not use them.
  2. Check your inventory against UDI-DI (01)00887868507793, lot 67818791, and expiration date (17) 360407.
  3. 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: 475620 Product Description: Intramedullary Bone Saw Blade Assembly 12mm
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 5 products — see all of them.

Details

Units affected
10
Illnesses reported
None reported
Manufactured in
56 E Bell Dr, Warsaw, IN, United States
Classification
Class II
Recall number
Z-2867-2026

In the FDA's words

Description
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475620 Product Description: Intramedullary Bone Saw Blade Assembly 12mm 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)00887868507793(17)360407(10)67818791; Lot 67818791 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: 10
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.

Related topics

SterilityMedical devicesSold nationwideMore from FDA Device