Home / Recalls / Synthes USA HQ, Inc. / Z-0408-2014

Z-0408-2014 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
166

Product Description

Slipped Capital Femoral Epiphysis System Product Usage: Intended for fracture fixation of large bones and large bone fragments and for slipped capital femoral epiphysis, pediatric femoral neck fractures, intercondylar femur fractures and sacroiliac joint disruptions.

Reason for Recall

There is a possibility for the Guide Wires of the Slipped Capital Femoral Epiphysis System to stick in the cannulation of the drill bit and the drill bits to break during surgery.

Distribution Pattern

USA Nationwide Distribution

Code Information

Parts 03.207.001 and 03.207.008 with lot numbers: Part # Lot # 03.207.001 PE00376 PE00439 PE01391 PE01329 PE01412 PE00504 03.207.008 PE00440 PE00377 PE00513 PE01475 PE01691

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)