OPUS Magnum 2 Plus Implant Product Number OM-1502 is a bone anchor Intended for rotator cuff repair in the shoulder.
Hazard
Product is being removed from the field due to an over-label issue.
What You Should Do
Remedy
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.
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Products
OPUS Magnum 2 Plus Implant Product Number OM-1502 is a bone anchor
Intended for rotator cuff repair in the shoulder.
- Brand
- Innovatech Medical Resources L.P.
- UPC
- Lot Numbers 120761, 120570, 120760, 120010, 1191150, and 120755
Units Affected
Lot number (Qty): 120761 (7 units), 120570 (6 units), 120760 (5 units), 120010 (1 units), 1191150 (1 units), and 120755 (24 units)