Biomet, Inc.: Orthopedic Manual Surgical Instrument
Zimmer Biomet is recalling Intramedullary Bone Saw Blade Assembly surgical instruments (15mm model 475635) because the exposed saw blade can damage the sterile packaging, potentially compromising the sterility of the device. This is a Class I recall affecting hospitals and surgical centers that received these products. The specific facilities affected are listed in the company's distribution documents.
- Recalling firm
- Biomet, Inc.
- Product
- Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475635 Product Description: Intramedullary Bone Saw Blade Assembly 15mm
- 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/3296b0d6-0f8e-46a4-88b8-477bf635fc1f