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Terminated

The Triathlon Posteriorly Stabilized Femoral Component.

FDA Recall Z-0556-05 · Posted 2005-02-24

Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeNPJ
Date Initiated2004-10-27
Date Terminated2005-05-31
Product Quantity386 UNITS

Reason for Recall

The fatigue testing of the Triathlon PS Femoral Component does not consistently meet the requirements of the finite element analysis predicted load as delineated in the 510(k) submittal.

Firm Action

Notification letters and Product Accountability Froms have been sent via Fedex on 10/27/2004 with return receipt.

Root Cause

Other

Distribution Pattern

The product is distributed to its branches/agencies and to hospitals nationwide.

Official Source

View FDA Recall →

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

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