FDA-Device2013-08-07Class II
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.
Stryker Howmedica Osteonics Corp.
Hazard
Stryker Osteosynthesis has become aware that LEFT GAMMA3 nails are marked as right nails.
Sold states
US Distribution including the states of IL, KY and TN.
Affected count
5 units
Manufactured in
325 Corporate Dr, N/A, Mahwah, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1846-2013Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief