Home / Recalls / Synthes USA HQ, Inc. / Z-0429-2014

Z-0429-2014 Class II Terminated

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

FDA device recall Z-0429-2014 was initiated by Synthes USA HQ, Inc. on Aug 1, 2013 and is designated Class II. Reason for recall: The small extendible Soft Tissue Retractor was recalled due to locking nut (clamping sleeve) malfunction. The recall status is terminated (terminated Apr 16, 2015). Affected quantity: 374.

Recall Details

Product Type
Devices
Report Date
Dec 11, 2013
Initiation Date
Aug 1, 2013
Termination Date
Apr 16, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
374

Product Description

Synthes Soft Tissue Retractor Small Extendible. Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous plate insertion.

Reason for Recall

The small extendible Soft Tissue Retractor was recalled due to locking nut (clamping sleeve) malfunction.

Distribution Pattern

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

Code Information

Part J5957AC (old), and Part J5957F (new)

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-0405-2014 Class II — Synthes Implant Holder for Synfix (TM)-LR the Synthes Implant Holder for Synf (Oct 8, 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-0408-2014 Class II — Slipped Capital Femoral Epiphysis System Product Usage: Intended for fractu (Jul 31, 2013)

FDA data resources