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Terminated

OPUS Magnum 2 Plus Implant Product Number OM-1502 is a bone anchor Intended for rotator cuff repair in the shoulder.

FDA Recall Z-0608-2012 · Posted 2012-01-11

Recalling FirmInnovatech Medical Resources L.P.
Recall StatusTerminated
Product CodeMBI
Date Initiated2011-08-08
Date Terminated2012-09-27
Product QuantityLot number (Qty): 120761 (7 units), 120570 (6 units), 120760 (5 units), 120010 (1 units), 1191150 (1 units), and 120755 (24 units)

Reason for Recall

Product is being removed from the field due to an over-label issue.

Firm 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.

Root Cause

Reprocessing Controls

Distribution Pattern

Nationwide Distribution including Texas

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K083240OPUS MAGNUM2 AND OPUS MAGNUM X KNOTLESS FIXATION DEVICESArthrocare Corp. · 2009-01-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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