FDAFDA · Food and drugs·Recall number Z-1846-2013
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.
Published August 7, 2013 · Recall initiated: May 21, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Stryker Osteosynthesis has become aware that LEFT GAMMA3 nails are marked as right nails.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Distributor
- US Distribution including the states of IL, KY and TN.
- Lot
- Catalog Number- 33250400S Catalog Number 33250360S
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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