Device product
GAMMA3 System Long Nail Kit, R2.0, Ti, Left Distributed in USA by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 USA A single use device intended for the temporary fixation, correction of stabilization of the right femur. The kit consists of intramedullary nail and set screw. The kit is used in combination with lag screw and (distal) locking screws and end cap as well.
Z-1846-2013
Product summary
- Event
- Event 65646
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5 units
- Official record key
device-enforcement:Z-1846-2013
Official wording
Reason: Stryker Osteosynthesis has become aware that LEFT GAMMA3 nails are marked as right nails.
Code information: Catalog Number- 33250400S Catalog Number 33250360S
Distribution pattern: US Distribution including the states of IL, KY and TN.
Derived failure modes
-
Unknown
Stryker Osteosynthesis has become aware that LEFT GAMMA3 nails are marked as right nails.