OPUS SmartStitch Product Number OM-8178 is a suture cartridge For use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopedic surgeries.
FDA Recall Z-0612-2012 · Posted 2012-01-11
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Recalling FirmInnovatech Medical Resources L.P.
Recall StatusTerminated
Product CodeKOG
Date Initiated2011-08-08
Date Terminated2012-09-27
Product Quantity18 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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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