Device 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
Z-0871-2020
Product summary
- Event
- Event 84598
- Status
- Terminated
- Classification
- Class II
- Quantity
- 67 units
- Official record key
device-enforcement:Z-0871-2020
Official wording
Reason: Potential issue associated with the instrument -end of the shaft could fail to effectively mate with the broach
Code information: Lot Numbers: 827310, 711160, 203240
Distribution pattern: US Nationwide and Foreign: countries of Canada, CHINA, NETHERLANDS
Derived failure modes
-
Unknown
Potential issue associated with the instrument -end of the shaft could fail to effectively mate with the broach