Limacorporate S.p.A Recall 91613
Description: TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling)
Limacorporate S.p.A Recall 91613 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1261-2023 |
| Event ID | 91613 |
| Event Description | TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling) |
| Product Type | Devices |
| Distribution | U.S. Distribution to: TX |
| Quantity | 5 systems |
| Recall Reason | Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in its elbow prosthesis. |
| Device Classification | 20230322 |
| Device Code Info | Product Code: 1590.15.010 UDI-DI Code: 08033390128865 Lot Number: 2115522 Sterilization Lot Number: 2100241 |
| Center Classification Date | 20230316 |
| Recall Initiation Date | 20230125 |
| Recalling Firm | Limacorporate S.p.A |
| Initial Notification | Letter |
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