LFIT V40 Femoral Head 의 리콜

Recall

RC-2015-RN-00129-1

Class II

2015-02-24

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00129-1

Stryker orthopaedics has received three customer complaints for a single lot of a specific size of the 32mm -4 v40 lfit vitallium femoral heads reporting that the femoral head could not be assembled with its corresponding v40 stem trunnion. upon investigation it was found that the female taper of the femoral head was not machined per drawing specifications, leaving a lip protruding approximately 0.007in from the taper surface at the inner base of the femoral head. this lip prevented the femoral head from successfully assembling with the associated male stem trunnion.No adverse consequences or delays to surgery were reported for any of the three complaints.

No additional patient follow-up or monitoring is required apart from usual routine follow-up, which will identify any issue. Symptomatic patients will present to their Health Care Practitioner. If any potential hazard or harms are detected by the Health Care Practitioner the appropriate action shall be taken. This action has been closed-out on 03/08/2016.