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

Z-0429-2014 Class II Terminated

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

Recall Details

Product Type: Devices
Report Date: December 11, 2013
Initiation Date: August 1, 2013
Termination Date: April 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 (October 15, 2013)
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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-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-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-0408-2014 Class II — Slipped Capital Femoral Epiphysis System Product Usage: Intended for fractu (July 31, 2013)