Device product
Corin TriIFit TS SIZE 2, STANDARD TAPERED STEM, CEMENTLESS, REF 694.0002. Hip prosthesis component.
Z-1850-2021
Product summary
- Firm
- Corin Ltd
- Event
- Event 87959
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4 units
- Official record key
device-enforcement:Z-1850-2021
Official wording
Reason: Units from one batch of TriFit TS size 2 stem were found to be labeled as a TriFit CF size 7 stem. And vice versa.
Code information: Lot Number 465498
Distribution pattern: US Nationwide distribution in the state of TX.
Derived failure modes
-
Unknown
Units from one batch of TriFit TS size 2 stem were found to be labeled as a TriFit CF size 7 stem. And vice versa.