OPUS SpeedScrew Implant Product Number OM-6500 is a bone anchor Intended to be used for fixation of soft tissue to bones
FDA device recall Z-0614-2012 · 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
- MBI
- Quantity affected
- 7 Units
- 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 SPEEDSCREW SYSTEM (K101448) | Arthrocare Corp. | 2010-06-21 |