Gammas Set Screwdriver Instrument Set, Basic Stryker Trauma GmbH, Germany; Distributed by Howmedica Osteonics Corp., 325
FDA device recall Z-1627-2008 · 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.
- 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
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