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Terminated

Restoration Hip system Cylindrical Distal Extension. Catalog Numbers 1212-3105, 1212-3115, 1212-3125, and 1212-3195. Sizes 12.5mm, 11.5mm, 19.5mm, and 10.5mm extensions.

FDA Recall Z-0719-04 · Posted 2004-07-20

Recalling FirmStryker Howmedica Osteonics
Recall StatusTerminated
Product CodeLXH
Date Initiated2004-02-10
Date Terminated2004-06-09
Product Quantity20

Reason for Recall

The Cylindrical Distal Extensions were incorrectly coded and packaged.

Firm Action

Stryker Orthopaedics sent product recall letters to the Branch/Agency involved on 2/10/2004 via FedEx. International distributor was sent notification on 2/10/2004.

Root Cause

Other

Distribution Pattern

The 9 units were sent out to 2 US branch/agents and one international distributor.

Official Source

View FDA Recall →

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

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