PROFEMUR PLASMA Z CLASSIC STEM SIZE 7 STANDARD SHORT NECK
FDA Recall Z-1225-2022 · Posted None
Recalling FirmMicroPort Orthopedics Inc.
Recall StatusTerminated
Product CodeJDI
Date Initiated2022-05-04
Date Terminated2024-01-16
Product Quantity8 units
Reason for Recall
One manufacturing lot is missing the plasma-spray coating in the proximal region of the stem body.
Firm 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 the affected product, monitor patients per normal protocol, return affected product and sign and return the response form.
Root Cause
Process change control
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of FL, IN, MO, CA and the country of Canada.
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.