CLAW and CLAW II Plates (An internal fixation device for the stabilisation of fractured bones and/or bone fragments) 의 리콜

Recall

RC-2014-RN-00914-1

Class I

2014-08-27

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00914-1

As an outcome of an investigation from a field complaint, wright medical discovered that certain claw and claw ii plates were manufactured from an incorrect raw material. the raw material specified for claw and claw ii plates is stainless steel meeting the requirements of astm f139 in a cold worked condition, however the material used meets the requirements of astm f139 stainless steel, but is in an annealed condition, which has reduced strength and increased ductility.

Wright Medical is recalling affected stock from hospitals. Additionally, Wright Medical is advising surgeons that if the intended postoperative instructions are followed by the patient, the product will still perform as intended. If the patient does not follow instructions and bears weight on the plate prior to fusion the ductility of the material may increase the likelihood of malunion or non-union. Prophylactic revision surgery is not recommended. For more details, please see http://www.tga.gov.au/safety/alerts-device-claw-plates-140829.htm . This action has been closed-out on 16/05/2017.