FDA Medical devices recall ·
Intramedullary Bone Saw Blade Assembly Model recall
- Recall number
- Z-2870-2026
- Date
- (initiated July 1, 2026)
- Company / brand
- Biomet, Inc.
56 E Bell Dr, Warsaw, IN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 22
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475635 Product Description: Intramedullary Bone Saw Blade Assembly 15mm
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2870-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.