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.
FDA Recall Z-2228-2008 · Posted 2008-09-18
Advertisement
Recalling FirmOrthoPro LLC
Recall StatusTerminated
Product CodeKWD
Date Initiated2008-05-29
Date Terminated2008-09-24
Product Quantity210 units
Reason for Recall
Labeling presented conflicting information as to whether device was sterile or not.
Firm Action
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.
Root Cause
Labeling mix-ups
Distribution Pattern
AZ, CA, CO, FL, HI, IL, IN, MI, NY, OH, OR, PA, RI, TX, UT, VA, and WA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement