Recall Z-2244-2024 ยท HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
MicroPort Orthopedics Inc.
EVOLUTION MP Femoral CS/CR Non-Porous Non-porous MicroPort total knee replacement implants are for cemented use only.
| Date | Jul 1, 2024 (initiated May 3, 2024) |
| Status | Open, Classified |
| Reason | One confirmed incident has been received that EFSRN4PR, lot number MP1982170, Size 4 Evolution MP Non-Porous Femoral Right was opened during surgery and contained part number EFSRN3PL, lot number MP1982097, Size 3 Evolution MP Non-Porous Femoral Left in the packaging. |
| Root cause | Under Investigation by firm |
| Action | The recalling firm issued the FSN, dated 05/02/2024, via email. The required actions were to: Immediately check inventory and quarantine all subject product(s); COMPLETE AND RETURN the attached FSCA Acknowledgement; Inform MicroPort Orthopedics of any adverse event immediately; Return any affected product to: MicroPort Orthopedics Inc. 1481 Gulf Stream, Arlington, TN 38002. The consignee is to mark all return shipping boxes with RECALL on several sides for better identification and processing. |
| Quantity | 40 units |
| Distribution | International distribution in the country of China. There is no field inventory in the United States for either lot. |
| FDA record | Open on fda.gov |