Class II — MicroPort Orthopedics Inc.
| Recalling firm | MicroPort Orthopedics Inc. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | EVOLUTION® MP Femoral CS/CR Non-Porous Non-porous MicroPort total knee replacement implants are for cemented use only. |
| Quantity | 40 units |
| Distribution | International distribution in the country of China. There is no field inventory in the United States for either lot. |
| Initiated | 2024-05-03 |
| Classified | 2024-07-01 |
| Recall number | Z-2244-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — MicroPort Orthopedics Inc. (Z-2244-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/94729/
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