—#82031

Product

Offset Adaptor Trial - 4MM, Triathlon Revision Instruments. Non-Sterile; Howmedica Osteonics Corp: 325 Corporate Drive, Mahwah, NJ 07430. Indications for use include disabling joint disease of the knee.

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K070095
Affected lot / code info: Catalog number 5570-T-040; All Lot Numbers.

Why it was recalled

Triathlon Offset Adaptors may seize during surgery and the OR staff may be unable to disassemble the instrument using the removal tool.

Root cause (FDA determination)

Process control

Action the firm took

"Urgent Product Correction" letters dated April 16, 2009 were sent to all Stryker Representatives, Hospital Rick Management Departments, Hospital Chief of Orthopaedics, Surgeon and countries by Federal Express. The notice explains the Issue, Potential Hazards and Risk Mitigation Factors of the affected product(s) including a request to complete and return the Product Correction Form. For further questions, contact Stryker Orthopedics, Division of Regulatory Reporting at 201-831-5970.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430

Distribution

Distribution pattern: Worldwide Distribution.

Timeline

Recall initiated: 2009-04-16
Posted by FDA: 2009-07-23
Terminated: 2010-04-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #82031. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.