Class II — BioPro, Inc.
| Recalling firm | BIOPRO, INC. |
|---|---|
| Registered facility | BIOPRO, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ. |
| Product | Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MS, Part ID 17198 |
| Distribution | US Nationwide distribution in the states of CT, KY, NM, PA, TN, and SD. |
| Initiated | 2022-02-01 |
| Classified | 2022-02-28 |
| Terminated | 2024-02-28 |
| Recall number | Z-0691-2022 |
| 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 — BioPro, Inc. (Z-0691-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89605/
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