FDA Device recall Z-0682-2022
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 16813
- FDA Device
- Class II
- terminated
- Published 2022-03-09
On 2022-03-09 the FDA classified a Class II recall of Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 16813 by Biopro, citing 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 th….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0682-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-02-01 |
| Published | 2022-03-09 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Biopro |
| Distribution | US |
Product
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 16813
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.
Identifiers
| code_info | Lot Number: 128667; UDI: 00810012480086 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0682-2022%22
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