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Terminated

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 Recall Z-1627-2008 · Posted 2008-09-16

Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeHXX
Date Initiated2008-02-22
Date Terminated2010-10-25
Product Quantity43 total (single and kits)

Reason for Recall

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

Firm Action

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.

Root Cause

Finished device change control

Distribution Pattern

Class II Recall - Nationwide Distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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