Home / Recalls / Synthes USA HQ, Inc. / Z-0202-2014

Z-0202-2014 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
November 20, 2013
Initiation Date
October 3, 2013
Termination Date
August 26, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2979

Product Description

Synthes 8.5 MM Medullary Reamer Product Usage: An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, bmT, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.

Reason for Recall

Complaints were received for intraoperative reamer head breakages which can allow for unretrieved fragments of non-implant grade material.

Distribution Pattern

Worldwide Distribution: USA (Nationwide) and countries of: Canada and Mexico.

Code Information

Part No. 352.085 with lot numbers 20141 through 24510, and 4399543 through 5870257

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  • 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)
  • Z-0408-2014 Class II — Slipped Capital Femoral Epiphysis System Product Usage: Intended for fractu (July 31, 2013)