Home / Recalls / Synthes USA HQ, Inc. / Z-0473-2014

Z-0473-2014 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
December 18, 2013
Initiation Date
October 9, 2013
Termination Date
December 18, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2912

Product Description

Synthes TomoFix Plates The Synthes J5606-C TomoFix Osteotomy System is used for open and closed wedge osteotomies of the medial proximal tibia, lateral proximal tibia, medial and lateral distal femur, treatment of bone and joint deformities, fractures, and malalignment caused by injury or disease such as osteoarthritis.

Reason for Recall

A labeling correction was initiated related to the Surgical Technique Guide J5606-C "TomoFix Osteotomy System" due to the potential for a surgical delay if the surgeon inserts the superior screws at a lesser angle (4 or 6 degrees) and is not aware that those angles are not present.

Distribution Pattern

Worldwide Distribution - USA (nationwide) Canada and Mexico

Code Information

J5606-C

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-0405-2014 Class II — Synthes Implant Holder for Synfix (TM)-LR the Synthes Implant Holder for Synf (October 8, 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-0202-2014 Class II — Synthes 8.5 MM Medullary Reamer Product Usage: An orthopedic manual surgica (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)
  • Z-0408-2014 Class II — Slipped Capital Femoral Epiphysis System Product Usage: Intended for fractu (July 31, 2013)