Recalls / —
—#49727
Product
Howmedica Hip Fracture Stem System No. 4 Femoral Component Fenestrated Sterile REF Catalogue #6942-0-040 Made in Ireland
- FDA product code
- KWL — Prosthesis, Hip, Hemi-, Femoral, Metal
- Device class
- Class 2
- Medical specialty
- Orthopedic
- Affected lot / code info
- Hip Fracture Stem # 4; Catalog number 6942-0-040; Lot codes: 7567401, 7799201, 7868901, 7868902, 7868903, 7936001, 7936002, 8243001, 8243002, 9401001, 9948301, 9948302, 9948304, 14342101, 17596001, 17596002, 17810901, 17969201, 18062501, 18062502, 18062503, 8243003R, MPRTA.
Why it was recalled
Lack of assurance of Sterility (package integrity): Anomalies in seal width and strength that may affect the integrity of the sterile barrier.
Root cause (FDA determination)
Other
Action the firm took
Recall notification letters and product accountability forms were sent on 11/29 via Fed Ex with return receipt.
Recalling firm
- Firm
- Stryker Howmedica Osteonics Corp.
- Address
- 325 Corporate Dr, Mahwah, New Jersey 07430-2002
Distribution
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2006-11-28
- Posted by FDA
- 2007-01-13
- Terminated
- 2007-05-08
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #49727. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.