Recall Z-1261-2023 ยท JDC Prosthesis, Elbow, Constrained, Cemented
Limacorporate S.p.A
TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling)
| Date | Mar 16, 2023 (initiated Jan 25, 2023) |
| Status | Open, Classified |
| Reason | Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in its elbow prosthesis. |
| Root cause | Employee error |
| Action | On or about 01/25/2023, the firm sent a "VOLUNTARY CORRECTION" Letter via email to customers informing them that the firm has become aware that it incorrectly included low constraint Tema axle small components (not cleared for marketing in U.S.) with its high constraint humeral bodies system. According to the firm's records, 3 low constraint components were implanted between 12/10/2021 to 07/05/2022. Customers are being instructed to: LimaCorporate suggests to Surgeons and Hospitals where an affected device listed in Table 1 was implanted in combination with high constraint humeral bodies co |
| Quantity | 5 systems |
| Distribution | U.S. Distribution to: TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181362 | TEMA Elbow System Lima Corporate S.P.A., Feb 16, 2019 |