FDA Recall
Terminated
OPUS Minimagnum Implant Part Number OM-2500 is a bone anchor Intended for rotator cuff repair
Recall: Z-0628-2012
·
Initiated August 8, 2011
Recall
- Recall Number
- Z-0628-2012
- Event Number
- 60049
- Firm
- Innovatech Medical Resources L.P.
- FEI Number
- 3009124511
- Product Code
- HWC
- Status
- Terminated
- Root Cause
- Reprocessing Controls
- Initiated
- August 8, 2011
- Posted
- January 11, 2012
- Terminated
- September 27, 2012
- Address
- 5455 Honeysuckle Road, Midlothian, TX, 76065
Description
OPUS Minimagnum Implant Part Number OM-2500 is a bone anchor Intended for rotator cuff repair
Reason
Product is being removed from the field due to an over-label issue.
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.
Distribution
Nationwide Distribution including Texas
Quantity
Lot Number (QTY): 110730 (7 units), 110874 (2 units), 110400 (7 units), 119256 (1 unit) and 117489 (1 unit)