Recall Z-1846-2013— Stryker Howmedica Osteonics Corp.
Class II · Terminated
Class II FDA medical device recall by Stryker Howmedica Osteonics Corp., initiated 2013-05-21, terminated 2014-10-14. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Stryker Osteosynthesis has become aware that LEFT GAMMA3 nails are marked as right nails..
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-05-21
- Terminated
- 2014-10-14
- Firm location
- Mahwah, NJ, United States
Product 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 for recall
Stryker Osteosynthesis has become aware that LEFT GAMMA3 nails are marked as right nails.
Data sourced from openFDA. This site is unofficial and independent of the FDA.