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Terminated

Howmedica Hip Fracture Stem System No. 3 Femoral Component Fenestrated Sterile REF Catalogue #6942-0-030 Made in Ireland

FDA Recall Z-0474-2007 · Posted 2007-01-13

Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeKWL
Date Initiated2006-11-28
Date Terminated2007-05-08
Product Quantity540 units

Reason for Recall

Lack of assurance of Sterility (package integrity): Anomalies in seal width and strength that may affect the integrity of the sterile barrier.

Firm Action

Recall notification letters and product accountability forms were sent on 11/29 via Fed Ex with return receipt.

Root Cause

Other

Distribution Pattern

Nationwide

Official Source

View FDA Recall →

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

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