—#68632

Product

Gamma 3 System Set Screwdriver, Flexible Shaft; 4mm, This product is non-sterile 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: 1320-0231 Lot Code on Package label K409181, Lot code engraved on Screwdriver: K968226; Lot code on package label: K610297, Lot code engraved on Screwdriver: K782153; Lot code on package label; K645667, Lot code engraved on screwdriver: K533686; Lot code on package label: K688034, Lot code engraved on screwdriver: K887079; and Lot code on package label: K878962, Lot code engraved on screwdriver: K533686.

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. If the screwdriver tip were to deform intra-operatively, the correct positioning of the set screw would not be possible, which could lead to lateral or medial migration of the lag-screw.

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 #68632. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.