Recall Z-1850-2021 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Corin Ltd
Corin TriIFit TS SIZE 2, STANDARD TAPERED STEM, CEMENTLESS, REF 694.0002. Hip prosthesis component.
| Date | May 6, 2021 |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by firm |
| Action | Corin initiated the recall by email on 05/06/2021 and followed with a letter on 05/07/2021 disseminated by email. The firm is seeking the return of the product. |
| Quantity | 4 units |
| Distribution | US Nationwide distribution in the state of TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.