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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00184-1
Product Name/Description	DePuy Synthes Trauma DHS/DCS Impactor Tip Insert for DHS/DCS Impactor No. 338.280, Single Part number: 338.260 All lot numbers below 7985313 DHS/DCS & Impactor, for One-Step Insertion Technique, for No. 338.300 Part number: 338.280 All lot numbers below 8016184 ARTG number 153950
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	5/03/2015
Responsible Entity	Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes
Reason/Issue	The DHS/DCS Impactor is composed of two parts: a replaceable plastic tip which is the Insert for DHS/DCS Impactor (338.260), and a metallic shaft (338.280). No biocompatibility testing has ever been completed by the manufacturer, Synthes for the material (Polyamide 6.6 with 20% carbon fibre reinforcement, Tecamid 66 CF 20) for the insert and no evidence was found that it has been completed by other entities. Potential for harm exists due to the potential for device breakage and may include surgical delay and adverse tissue reaction.
Recall Action	Recall
Recall Action Instructions	Johnson & Johnson Medical is replacing the plastic tip of the insert with a metal tip. Once the redesigned tip is available Johnson & Johnson Medical will arrange for the recovery and replacement of the old impactor tip. In the interim to ensure the impactor is available for emergency surgery, Johnson & Johnson Medical has provided end users with inspection instructions to check for any wear and tear. Alternatively, hospitals can return the tip for a credit note. This action has been closed out on 14 June 2017.
Contact Information	1800 252 194 - Johnson & Johnson Medical Pty Ltd