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Terminated

5.0 mm Parafix Part Number 22-5011 is a suture anchor metal Intended for rotator cuff repair.

FDA Recall Z-0627-2012 · Posted 2012-01-11

Recalling FirmInnovatech Medical Resources L.P.
Recall StatusTerminated
Product CodeMBI
Date Initiated2011-08-08
Date Terminated2012-09-27
Product Quantity1 unit

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.

K042584OPUS MINIMAGNUM ANCHOR WITH INSERTEROpus Medical, Inc. · 2004-12-14

Official Source

View FDA Recall →

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

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