FDA
Metal Hemiarthroplasty, MDL E536687, Part # 03-6000-1, 03-6000-02, 03-600-03, 03-6000-04, OrthoPro LLC, Salt Lake City, UT Hemi is designed to supplement first metatarsal Phalangeal joint arthroplasty.
Labeling presented conflicting information as to whether device was sterile or not.
All sales agents were verbally notified on 05/29/2008 and told to locate and return all available affected implants. For assistance, contact OrthoPro at 1-801-746-0208.