Howmedica Hip Fracture Stem System No. 3.5 Femoral Component Uses No. 3 Fenestrated Plus Sterile REF Catalogue #6942-0-0
FDA device recall Z-0475-2007 · posted 2007-01-13 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- 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.
- Action taken
- Recall notification letters and product accountability forms were sent on 11/29 via Fed Ex with return receipt.
- Root cause
- Other
- Status
- Terminated
- Product code
- KWL
- Quantity affected
- 126 units
- Distribution
- Nationwide
- Date initiated
- 2006-11-28
- Date posted
- 2007-01-13
- Date terminated
- 2007-05-08
- Location
- Mahwah, NJ
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