Recall Z-2228-2008 ยท KWD Prosthesis, Toe, Hemi-, Phalangeal
OrthoPro LLC
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.
| Date | Sep 18, 2008 (initiated May 29, 2008) |
| Status | Terminated |
| Reason | Labeling presented conflicting information as to whether device was sterile or not. |
| Root cause | Labeling mix-ups |
| 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. |
| Quantity | 210 units |
| Distribution | AZ, CA, CO, FL, HI, IL, IN, MI, NY, OH, OR, PA, RI, TX, UT, VA, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071243 | METAL HEMI IMPLANT Orthopro, LLC, May 23, 2007 |