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Synthes USA HQ, Inc. recalls Synthes Tensioning Device The Synthes Osteogenesis System, MR Conditional is intended for fracture fixation (open an
Recalled December 4, 2013 · FDA recall Z-0388-2014 · Synthes USA HQ
Hazard
All lots of the Synthes Tensioning Device were recalled due to the potential for the reaction fork to come loose from the main body of the device and not allow the wire to release, nor the device to apply tension. · FDA Class II
Units
369
Sold at
Nationwide Distribution.
Description
All lots of the Synthes Tensioning Device were recalled due to the potential for the reaction fork to come loose from the main body of the device and not allow the wire to release, nor the device to apply tension.
Product
Synthes Tensioning Device The Synthes Osteogenesis System, MR Conditional is intended for fracture fixation (open and closed), pseudoarthrosis or non-unions of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformities and correction of segmental bony or soft tissue defects in adult and pediatric patients.
Manufacturer(s)
Synthes USA HQ, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →