FDA Enforcement
Class II
Terminated
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.
Recall: Z-1846-2013
·
Reported August 7, 2013
Enforcement
- Recall Number
- Z-1846-2013
- Event ID
- 65646
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Stryker Howmedica Osteonics Corp.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 7, 2013
- Initiation Date
- May 21, 2013
- Classification Date
- July 31, 2013
- Termination Date
- October 14, 2014
- Address
- 325 Corporate Dr, N/A, Mahwah, NJ, 07430-2002, United States
Description
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.
Reason
Stryker Osteosynthesis has become aware that LEFT GAMMA3 nails are marked as right nails.
Code Info
Catalog Number- 33250400S Catalog Number 33250360S
Distribution
US Distribution including the states of IL, KY and TN.
Quantity
5 units