DePuy Synthes Trauma DHS/DCS Impactor TipInsert for DHS/DCS Impactor No. 338.280, Single 의 리콜

Recall

RC-2015-RN-00184-1

Class II

2015-03-05

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00184-1

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.

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.