Home / Recalls / Synthes USA HQ, Inc. / Z-0388-2014

Z-0388-2014 Class II Terminated

Recalled by Synthes USA HQ, Inc. — West Chester, PA

Recall Details

Product Type
Devices
Report Date
December 4, 2013
Initiation Date
July 31, 2013
Termination Date
June 1, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
369

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.

Distribution Pattern

Nationwide Distribution.

Code Information

all lots of model number 03.311.001: Part # Synthes lot # 03.311.001 1934765 03.311.001 1934766 03.311.001 1993844 03.311.001 3036688 03.311.001 3398576 03.311.001 3776484 03.311.001 5100597 03.311.001 5106354 03.311.001 5160872 03.311.001 5160875 03.311.001 5174253 03.311.001 5174253 03.311.001 5174254 03.311.001 5181000 03.311.001 5181001 03.311.001 5196282 03.311.001 5196283 03.311.001 5197081 03.311.001 5241942 03.311.001 5241943 03.311.001 5336723 03.311.001 5363637 03.311.001 5396016 03.311.001 5411479 03.311.001 5555521

Other recalls by Synthes USA HQ, Inc.

  • Z-0393-2014 Class II — Synthes Material Mix (Adjustable Cervical Distractor-Right, Matrix Distractor Ra (October 15, 2013)
  • Z-0473-2014 Class II — Synthes TomoFix Plates The Synthes J5606-C TomoFix Osteotomy System is used f (October 9, 2013)
  • Z-0405-2014 Class II — Synthes Implant Holder for Synfix (TM)-LR the Synthes Implant Holder for Synf (October 8, 2013)
  • Z-0202-2014 Class II — Synthes 8.5 MM Medullary Reamer Product Usage: An orthopedic manual surgica (October 3, 2013)
  • Z-0394-2014 Class II — Synthes Spiked Washers 13.5/6.5 Spiked Washers 13.5/6.5 are intended to be us (October 3, 2013)
  • Z-0369-2014 Class II — Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade Synthes Titan (October 3, 2013)
  • Z-0455-2014 Class II — Synthes Zero-P VA Implant 7 MM Height Parallel Sterile The Synthes Zero-P VA (September 30, 2013)
  • Z-0341-2014 Class II — Synthes Soft Tissue Retractor Small Extendible Offset blade facilitates easy (September 24, 2013)
  • Z-0114-2014 Class II — Synthes Application Instrument Sternal Zip Flex System intended for use in pr (August 13, 2013)
  • Z-0429-2014 Class II — Synthes Soft Tissue Retractor Small Extendible. Offset blade facilitates easy (August 1, 2013)