Recall Z-0628-2012 ยท HWC Screw, Fixation, Bone
Innovatech Medical Resources L.P.
OPUS Minimagnum Implant Part Number OM-2500 is a bone anchor Intended for rotator cuff repair
| 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): 110730 (7 units), 110874 (2 units), 110400 (7 units), 119256 (1 unit) and 117489 (1 unit) |
| Distribution | Nationwide Distribution including Texas |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042584 | OPUS MINIMAGNUM ANCHOR WITH INSERTER Opus Medical, Inc., Dec 14, 2004 |