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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-01638-1
Product Name/Description	DePuy Synthes Impactor for PFNA Blade Part Number: 03.010.410 All Lots ARTG Number: 153950
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	15/12/2016
Responsible Entity	Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes
Reason/Issue	DePuy Synthes Trauma has received product complaints for breakage in the PFNA Blade Impactor, where the handle detached from the shaft of the instrument. It has been identified that a laser weld breakage, partial or complete, can occur in the PFNA Blade Impactor where the handle detaches from the internal shaft of the instrument. In the event that the laser welding of the handle cracks, the handle may loosen or separate from the instrument. If the issue is detected during use, a marginal surgical delay may occur if the handle cracks, loosens, or separates. Infection could potentially result if the handle is loosened from the shaft and allows body fluids (i.e. blood, bony debris) to enter the interior of the impactor’s handle.
Recall Action	Recall
Recall Action Instructions	Customers are advised to immediately quarantine the product and return it to JJM. If they have any questions about alternative devices, they are advised to contact DePuy Synthes Trauma. This action has been closed out on 08/08/2019
Contact Information	1800 252 194 - Johnson & Johnson Medical