Recalls / —
—#78919
Product
Stryker Howmedica Osteonics, Primary Super SecurFit Stems, hip prosthesis, Sterile; Arc Deposited, V40 taper Not for use with 16mm heads.
- FDA product code
- MEH — Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K020615
- Affected lot / code info
- Catalog Number: J6054-XXXX; All lots codes with an expiry prior to Aug. 2013.
Why it was recalled
Stryker Orthopaedics became aware that there may be difficulty in mating stem to implantation/extraction instrument.
Root cause (FDA determination)
Device Design
Action the firm took
Stryker sent Urgent product Correction Letters on January 14, 2009 by Federal Express to Stryker branches/agencies, hospital risk management, chief of orthopaedics and surgeon.
Recalling firm
- Firm
- Stryker Howmedica Osteonics Corp.
- Address
- 325 Corporate Dr, Mahwah, New Jersey 07430
Distribution
- Distribution pattern
- Nationwide. Product was distributed to 3 Stryker branches/agencies and 2 hospitals in PA and CA.
Timeline
- Recall initiated
- 2009-01-14
- Posted by FDA
- 2009-12-22
- Terminated
- 2012-07-18
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #78919. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.