OPUS Minimagnum Implant Part Number OM-2500 is a bone anchor Intended for rotator cuff repair
FDA device recall Z-0628-2012 · posted 2012-01-11 · Terminated
Recall details
- Recalling firm
- Innovatech Medical Resources L.P.
- Reason for recall
- Product is being removed from the field due to an over-label issue.
- Action taken
- 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.
- Root cause
- Reprocessing Controls
- Status
- Terminated
- Product code
- HWC
- Quantity affected
- Lot Number (QTY): 110730 (7 units), 110874 (2 units), 110400 (7 units), 119256 (1 unit) and 117489 (1 unit)
- Distribution
- Nationwide Distribution including Texas
- Date initiated
- 2011-08-08
- Date posted
- 2012-01-11
- Date terminated
- 2012-09-27
- Location
- Midlothian, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OPUS MINIMAGNUM ANCHOR WITH INSERTER (K042584) | Opus Medical, Inc. | 2004-12-14 |