Recall Z-0608-2012 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
Innovatech Medical Resources L.P.
OPUS Magnum 2 Plus Implant Product Number OM-1502 is a bone anchor Intended for rotator cuff repair in the shoulder.
| Date | Jan 11, 2012 (initiated Aug 8, 2011) |
| Status | Terminated |
| Reason | Product is being removed from the field due to an over-label issue. |
| Root cause | Reprocessing Controls |
| Action | Innovatech Medical Resources L.P. decided to recall all products resterilized and overlabeled at their facility. A firm representative would visit each customer and request that they remove the overlabeled product from their shelves and secure it. Customers could call the MSI office to get a RMA (Return Materials Authorization) for a refund on this product. For questions regarding this recall call 817-714-9066. |
| Quantity | Lot number (Qty): 120761 (7 units), 120570 (6 units), 120760 (5 units), 120010 (1 units), 1191150 (1 units), and 120755 |
| Distribution | Nationwide Distribution including Texas |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083240 | OPUS MAGNUM2 AND OPUS MAGNUM X KNOTLESS FIXATION DEVICES Arthrocare Corp., Jan 12, 2009 |