Biomet, Inc.: Orthopedic Manual Surgical Instrument
Recall Summary Zimmer Biomet is recalling Intramedullary Bone Saw Blade Assemblies (model 475630, 14mm size) used in orthopedic surgery because the sterile packaging may be damaged from the exposed saw blade inside. This is a Class I recall, meaning there is a reasonable probability that use of the product could cause serious injury or death. The affected products were distributed to specific hospitals and medical facilities listed in the company's distribution records.
- Recalling firm
- Biomet, Inc.
- Product
- Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475630 Product Description: Intramedullary Bone Saw Blade Assembly 14mm
- 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/3b6fed80-e3ca-4afc-9a01-7898de6b6b7f