—#90574

Product

Howmedica Osteonics Corp, Stryker Orthopaedics Passport A.R. Knee Instrumentation Distal Guide Stand; Catalog number 7650-5005.

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Catalog number 7650-5005. All lots.

Why it was recalled

There is the potential for the posts on the Distal Resection Guide Stand to disassociate from the main body part.

Root cause (FDA determination)

Device Design

Action the firm took

Stryker Urgent Product Recall letters dated April 8, 2010, were sent by Federal Express to Stryker Branches/agencies, Hospital Risk Management, Hospital Chief of Orthopaedics and Surgeons. All hospitals and surgeons that used the product in the last year were notified.

Recalling firm

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

Distribution

Distribution pattern: Worldwide distribution.

Timeline

Recall initiated: 2010-04-05
Posted by FDA: 2010-08-02
Terminated: 2012-08-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #90574. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.