PCA Tapers, LFIT V40 Tapers, V40 Tapers (Vitallium Femoral Heads) 의 리콜

Recall

RC-2015-RN-00922-1

Class II

2015-10-01

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00922-1

Stryker has received four customer complaints for lfit v40 vitallium femoral heads (manufactured july 7th 2014 – august 15th 2014) reporting that the femoral head could not be assembled with its corresponding v40 stem trunnion at the time of surgery. upon investigation it was found that the female v40 taper of the four complaint devices were not machined per drawing specifications, leaving a lip protruding from the taper surface at the inner base of the femoral head. this lip prevented the femoral head from successfully locking with the associated male stem trunnion. in each case a new v40 lfit vitallium femoral head was opened and used. no other adverse consequences or delays to surgery were reported for any of these complaints.

Stryker is advising users to inspect stock and quarantine any affected devices. Stryker will replace any affected devices with unaffected devices. A femoral head that has not achieved a taper lock will be clearly evident during verification, thus reducing the occurrence of the implantation of an unlocked femoral head.