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Terminated

T2 Proximal Humeral System Targeting Arm. Catalog number 1806-2035.

FDA Recall Z-0994-04 · Posted 2004-07-20

Recalling FirmHowmedica Osteonics Corp.
Recall StatusTerminated
Product CodeLXH
Date Initiated2004-03-31
Date Terminated2004-06-03
Product Quantity32 devices

Reason for Recall

Targeting device may become distorted upon repeated autoclaving.

Firm Action

On March 31, 2004 recall letters and product accountability forms were sent via FedEx.

Root Cause

Other

Distribution Pattern

There were 19 consignees which are Stryker sales representatives and subsidiaries nationwide.

Official Source

View FDA Recall →

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

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