Recall Z-1225-2022 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
MicroPort Orthopedics Inc.
PROFEMUR PLASMA Z CLASSIC STEM SIZE 7 STANDARD SHORT NECK
| Date | May 4, 2022 |
| Status | Terminated |
| Reason | One manufacturing lot is missing the plasma-spray coating in the proximal region of the stem body. |
| Root cause | Process change control |
| Action | The firm sent out a recall notification to the distributors on 05/04/2022 via email. Phone calls were also made to the distributors. Additionally, the US field communication letter was mailed to the surgeon and facility in regard to the one case of implantation on May 10, 2022. The consignee letter informed the consignee to cease use and distribution of the affected product, check inventory for affected product, complete the response form, return affected product and notify affected consignees. The field surgeon letter and hospital letter informs the consignee to cease use and distribution of |
| Quantity | 8 units |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of FL, IN, MO, CA and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123434 | PROFEMUR Z CLASSIC STEMS Wrightmedicaltechnologyinc, Feb 5, 2013 |