Device product
ASI 2.0 Calcar Trimmer Shaft for Use with Biomet¿ Rasp, Model Number 110032331
Z-0517-2020
Product summary
- Event
- Event 84124
- Status
- Terminated
- Classification
- Class II
- Quantity
- 73
- Official record key
device-enforcement:Z-0517-2020
Official wording
Reason: The potential that the end of the shaft could fail to effectively mate with the broach with the Calcar Planar Shaft instrument, part number 110032331.
Code information: Model Number: 11032331 Lots: 784060, 662870
Distribution pattern: CA, IN, MN, NJ, NY, AR, LA, OH, KY, TX, CO (US) CA, CN, NL (International)
Derived failure modes
-
Unknown
The potential that the end of the shaft could fail to effectively mate with the broach with the Calcar Planar Shaft instrument, part number 110032331.