Recall Z-1225-2022
MicroPort Orthopedics Inc. · initiated May 4, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
PROFEMUR PLASMA Z CLASSIC STEM SIZE 7 STANDARD SHORT NECK
Codes / lots: Catalog Number(s): PHAPCLS7; Lot Number(s): 1903727; Expiration Date: 11/24/2029; UDI/DI Number: 00192629112773
Reason for recall
One manufacturing lot is missing the plasma-spray coating in the proximal region of the stem body.
FDA-determined cause: Process change control
Action taken
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.
Details
- Recall number
- Z-1225-2022
- Initiated
- May 4, 2022
- Terminated
- January 16, 2024
- Product code
- JDI – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- Quantity
- 8 units
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of FL, IN, MO, CA and the country of Canada.
- Recalling firm
- MicroPort Orthopedics Inc., Arlington, TN