Recalls / —
—#85497
Product
Stryker Howmedica Osteonics, Skirted 5 40' Taper V40 Femoral Head (26 mm +8mm offset), hip prosthesis component.
- FDA product code
- JDG — Prosthesis, Hip, Femoral Component, Cemented, Metal
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K010757, K022077, K061434, K993601
- Affected lot / code info
- Catalog number 6260-5-326; Lot code 29018201
Why it was recalled
Packaging mix up between the Taper V40 Femoral Head and the LFIT V40 Femoral Head.
Root cause (FDA determination)
Process control
Action the firm took
Stryker sent Notification letters and Product Accountability Forms via FedEx on September 4, 2009 with return receipt. Corrected letters were sent on September 9, 2009.
Recalling firm
- Firm
- Stryker Howmedica Osteonics Corp.
- Address
- 325 Corporate Drive, Mahwah, New Jersey 07430
Distribution
- Distribution pattern
- Nationwide distribution.
Timeline
- Recall initiated
- 2009-09-04
- Posted by FDA
- 2009-11-23
- Terminated
- 2013-06-26
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #85497. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.