Home / Recalls / Synthes USA HQ, Inc. / Z-0405-2014

Z-0405-2014 Class II Terminated

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

FDA device recall Z-0405-2014 was initiated by Synthes USA HQ, Inc. on Oct 8, 2013 and is designated Class II. Reason for recall: Complaints were received which described the SynFix LR implant holder breaking at the interface between the implant and the holder. The recall status is terminated (terminated Aug 26, 2016). Affected quantity: 548.

Recall Details

Product Type
Devices
Report Date
Dec 4, 2013
Initiation Date
Oct 8, 2013
Termination Date
Aug 26, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
548

Product Description

Synthes Implant Holder for Synfix (TM)-LR the Synthes Implant Holder for Synfix (TM)-LR is a non-powered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery

Reason for Recall

Complaints were received which described the SynFix LR implant holder breaking at the interface between the implant and the holder.

Distribution Pattern

Worldwide Distribution - USA (nationwide) and Internationally to Canada .

Code Information

all lots of part no. 03.802.039

Other recalls by Synthes USA HQ, Inc.

  • Z-0393-2014 Class II — Synthes Material Mix (Adjustable Cervical Distractor-Right, Matrix Distractor Ra (Oct 15, 2013)
  • Z-0473-2014 Class II — Synthes TomoFix Plates The Synthes J5606-C TomoFix Osteotomy System is used f (Oct 9, 2013)
  • Z-0369-2014 Class II — Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade Synthes Titan (Oct 3, 2013)
  • Z-0202-2014 Class II — Synthes 8.5 MM Medullary Reamer Product Usage: An orthopedic manual surgica (Oct 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 (Oct 3, 2013)
  • Z-0455-2014 Class II — Synthes Zero-P VA Implant 7 MM Height Parallel Sterile The Synthes Zero-P VA (Sep 30, 2013)
  • Z-0341-2014 Class II — Synthes Soft Tissue Retractor Small Extendible Offset blade facilitates easy (Sep 24, 2013)
  • Z-0114-2014 Class II — Synthes Application Instrument Sternal Zip Flex System intended for use in pr (Aug 13, 2013)
  • Z-0429-2014 Class II — Synthes Soft Tissue Retractor Small Extendible. Offset blade facilitates easy (Aug 1, 2013)
  • Z-0408-2014 Class II — Slipped Capital Femoral Epiphysis System Product Usage: Intended for fractu (Jul 31, 2013)

FDA data resources