—#68633

Product

Gammas Set Screwdriver Instrument Set, Basic Stryker Trauma GmbH, Germany; Distributed by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 - Orthopedic Device. The Gamma3 Locking Nail Systems are intramedullary short and long fixation nails intended for control of rotation and shortening of fractured femurs. The screwdriver is used to place the set screw in the nail.

FDA product code: HXX — Screwdriver
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Product number: 1320-6000; Lot code engraved on screwdrivers: K887079 and K782153.

Why it was recalled

Stryker Trauma has become aware that five lots of the Gamma3 Set Screwdriver have hexagon tips that were not hardened to specification.

Root cause (FDA determination)

Finished device change control

Action the firm took

On February 22, 2008 Urgent Product Recall notification letters were sent to Stryker Branches/Agencies, Risk Management Departments at hospitals and surgeons via Federal Express. If you have any questions contact Rita Intorrella at (201) 831-5825 or the Hip Fracture Team at (201) 831-5291.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430-2002

Distribution

Distribution pattern: Class II Recall - Nationwide Distribution.

Timeline

Recall initiated: 2008-02-22
Posted by FDA: 2008-09-16
Terminated: 2010-10-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #68633. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.