Recall Z-0871-2020— Zimmer Biomet, Inc.
Class II · Terminated
Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2019-12-19, terminated 2020-08-11. FDA's recall record names no specific 510(k) clearance for this event. Product: ASI 2.0 Calcar Trimmer Shaft for Use with Zimmer Rasp Mode Number: 110032332 Product Usage: The device is a general orthopedic manual surgical instrument. Reason: Potential issue associated with the instrument -end of the shaft could fail to effectively mate with the broach.
- Recalling firm
- Zimmer Biomet, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-12-19
- Terminated
- 2020-08-11
- Firm location
- Warsaw, IN, United States
Product description
ASI 2.0 Calcar Trimmer Shaft for Use with Zimmer Rasp Mode Number: 110032332 Product Usage: The device is a general orthopedic manual surgical instrument
Reason for recall
Potential issue associated with the instrument -end of the shaft could fail to effectively mate with the broach
Data sourced from openFDA. This site is unofficial and independent of the FDA.