Linkbio Corp. Recall 92294
Description: LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz 5-6 Tilastan, cemented. Intended for primary and revision total knee replacement. Item Number: 880-325/13
Linkbio Corp. Recall 92294 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1674-2023 |
| Event ID | 92294 |
| Event Description | LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz 5-6 Tilastan, cemented. Intended for primary and revision total knee replacement. Item Number: 880-325/13 |
| Product Type | Devices |
| Distribution | US Nationwide Distribution - AL, GA, IL, IN, LA, NV, TX |
| Quantity | 11 units |
| Recall Reason | Contains the incorrect implant in the packaging. The packaging incorrectly contains the opposite side of the implant (Lateral-Right/Medial-Left instead of Medial-Right/Lateral-Left). |
| Device Classification | 20230607 |
| Device Code Info | UDI-DI : 04026575258123 Lot Number: 1910003 |
| Center Classification Date | 20230601 |
| Recall Initiation Date | 20230425 |
| Recalling Firm | Linkbio Corp. |
| Initial Notification | |
| Similar To |