Howmedica Hip Fracture Stem System No. 4 Femoral Component Fenestrated Sterile REF Catalogue #6942-0-040 Made in Ireland
FDA Recall Z-0476-2007 · Posted 2007-01-13
Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeKWL
Date Initiated2006-11-28
Date Terminated2007-05-08
Product Quantity67 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.