Gamma 3 System Set Screwdriver, Flexible Shaft; 4mm, This product is non-sterile Stryker Trauma GmbH, Germany; Distribut

FDA device recall Z-1626-2008 · posted 2008-09-16 · Terminated

Recall details

Recalling firm

Stryker Howmedica Osteonics Corp.

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. 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.

Action taken

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

Status

Terminated

Product code

HXX

Quantity affected

43 total (single and kits)

Distribution

Class II Recall - Nationwide Distribution.

Date initiated

2008-02-22

Date posted

2008-09-16

Date terminated

2010-10-25

Location

Mahwah, NJ