Recall Z-0388-2014— Synthes USA HQ, Inc.
Class II · Terminated
Class II FDA medical device recall by Synthes USA HQ, Inc., initiated 2013-07-31, terminated 2015-06-01. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..
- Recalling firm
- Synthes USA HQ, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-07-31
- Terminated
- 2015-06-01
- Firm location
- West Chester, PA, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.