Home / Recalls / Synthes USA HQ, Inc. / Z-0474-2014

Z-0474-2014 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
December 18, 2013
Initiation Date
July 30, 2013
Termination Date
September 10, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
12

Product Description

Synthes Trochanteric Fixation Nail As part of the Synthes Trochanteric Fixation Nail (TFN) System, the TFN Nail is intended to treat stable and unstable fractures of the proximal femur.

Reason for Recall

Certain lots of Trochanteric Fixation Nail were distributed to the field with the incorrect labeling of the length and diameter of the nail on the packaging.

Distribution Pattern

Nationwide Distribution including WA, FL, LA, TX, GA, IN, OH, CA, MI, and PA.

Code Information

Part 456.475S, lot # 7121831 and Part 456.637S, lot #7121832, expiration 11/30/21.

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-0369-2014 Class II — Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade Synthes Titan (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-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)