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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-01094-1
Product Name/Description Attachment for Acetabular and Medullary Reaming (used with the Compact Air Drive II, an air-driven power tool for use in traumatology, endoprosthetics and spinal column surgery)

Product Number 511.785

Serial Numbers: 16384,16385,16386,16387,16389,16390,16391,16392,16393, 16394,16395,16396,16397,16403,16405,1641

ARTG Number: 157072
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 10/11/2015
Responsible Entity Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes
Reason/Issue The geometrical shape of a subcomponent of this attachment was inadvertently changed. This change allows potential unintended reverse (counter-clockwise) motion if the subcomponent is aligned in a specific orientation when the attachment is connected to the handpiece and both triggers are pressed.

This attachment is intended to be used without reverse motion. Unintentional activation in reverse could potentially damage flexible drilling or reaming shafts and could potentially cause serious injury to the patient.
Recall Action Recall
Recall Action Instructions Customer to return affected product. Sponsor to replace affected product. This action has been closed-out on 24/08/2016.
Contact Information 1300 562 711 - JJM Cusotmer Service