Biomet, Inc.: Orthopedic Manual Surgical Instrument
Zimmer Biomet is recalling the Intramedullary Bone Saw Blade Assembly (16mm, Model 475640), a surgical instrument used in orthopedic procedures. The saw blade can damage the sterile packaging during manufacturing, potentially compromising the sterility of the device. The recall affects medical facilities and surgical centers that received these instruments, as identified in the company's distribution records.
- Recalling firm
- Biomet, Inc.
- Product
- Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475640 Product Description: Intramedullary Bone Saw Blade Assembly 16mm
- Reason
- 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.
- Classification
- Class I
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-07-01
- Status
- Open, Classified
- 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.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/8a8e6960-8b75-47ff-b7da-4e64184317d9