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Terminated

Stryker T2 Locking Screw, Fully threaded; 05 x 70mm, Catalog Number: 1896-5070S, Sterile, Qty: 1,Stryker Trauma GMbH, 24232 Schonkirchen, Germany Distributed in the United States by Howmedica Osteonics Corp.; 325 Corporate Drive, Mahwah, NJ 07430

FDA Recall Z-0214-2008 · Posted 2007-11-16

Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Date Initiated2007-09-27
Date Terminated2008-05-08
Product Quantity50

Reason for Recall

Mislabeled: One lot of screws (05x70mm) is labeled as containing 70mm, but may actually contain 75mm length screws.

Firm Action

Urgent Product Recall letters were sent on September 27, 2007, to all Stryker Branches/Agencies and hospitals who received the product requesting them to remove and quarantine the product for Stryker pick-up.

Root Cause

Packaging process control

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K003018TITAN TIBIAL NAILHowmedica Osteonics Corp. · 2000-12-15

Official Source

View FDA Recall →

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

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