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Stryker Howmedica Osteonics Corp. recalls GAMMA3 System Long Nail Kit, R2.0, Ti, Left Distributed in USA by Howmedica Osteonics Corp., 325 Corporate Drive, Mah
Recalled August 7, 2013 · FDA recall Z-1846-2013 · Stryker Howmedica Osteonics
Hazard
Stryker Osteosynthesis has become aware that LEFT GAMMA3 nails are marked as right nails. · FDA Class II
Units
5 units
Sold at
US Distribution including the states of IL, KY and TN.
Description
Stryker Osteosynthesis has become aware that LEFT GAMMA3 nails are marked as right nails.
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.
Manufacturer(s)
Stryker Howmedica Osteonics Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →