BioPro, Inc. Recall 89605
Description: Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MD, Part ID 16814
BioPro, Inc. Recall 89605 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0683-2022 |
| Event ID | 89605 |
| Event Description | Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MD, Part ID 16814 |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of CT, KY, NM, PA, TN, and SD. |
| Recall 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. |
| Device Classification | 20220309 |
| Device Code Info | Lot Number: 125423, 128356; UDI: 00810012480093 |
| Center Classification Date | 20220228 |
| Recall Initiation Date | 20220201 |
| Recalling Firm | BioPro, Inc. |
| Initial Notification | Letter |
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