Z-0871-2020 Class II Terminated
FDA device recall Z-0871-2020 was initiated by Zimmer Biomet, Inc. on December 19, 2019 and is designated Class II. Reason for recall: Potential issue associated with the instrument -end of the shaft could fail to effectively mate with the broach The recall status is terminated (terminated August 11, 2020). Affected quantity: 67 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 5, 2020
- Initiation Date
- December 19, 2019
- Termination Date
- August 11, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 67 units
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
Distribution Pattern
US Nationwide and Foreign: countries of Canada, CHINA, NETHERLANDS
Code Information
Lot Numbers: 827310, 711160, 203240