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Type of Product Medical Device
TGA Recall Reference RC-2018-RN-00334-1
Product Name/Description Sciatic Nerve Retractors

Part Numbers: 03.100.013, 03.100.014

Lot Numbers: T140390, T140675, T140677 ,T145819, T140566, T140673, T151369

ARTG Number: 296161
Johnson & Johnson Medical t/a DePuy Synthes - Wound retractor, intermediate/deep
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 18/04/2018
Responsible Entity Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes
Reason/Issue Johnson and Johnson has identified the potential for micropores to form on the hollow handle of the Sciatic Nerve Retractor. The pores may increase in size, allowing fluid to enter the hollow handle.

Discoloration and moisture were identified within the packaging of the affected lots of Sciatic Nerve Retractors indicating that these pores may be present in the affected devices.

Even with diligent reprocessing/sterilisation of the retractor, subsequent patients may be at risk for infection and adverse tissue reaction due to retained fluids leaking out during use.
Recall Action Recall
Recall Action Instructions Johnson and Johnson are advising users to inspect stock and return any affected product as soon as possible.

This action has been closed out on 21/06/2019
Contact Information 1800 252 194 - Johnson & Johnson Medical