Recall Z-0611-2012 ยท GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Innovatech Medical Resources L.P.
OPUS SpeedStitch Product Number OM-8086 is a suture cartridge For use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopedic surgeries.
| 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): 1000044 (17 units) and 1000162 (10 units) |
| Distribution | Nationwide Distribution including Texas |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042031 | OPUS SPEEDSTITCH SUTURE DEVICE Opus Medical, Inc., Oct 19, 2004 |