Z-0690-2022 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 9, 2022
- Initiation Date
- February 1, 2022
- Termination Date
- February 28, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MS, Part ID 17197
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution in the states of CT, KY, NM, PA, TN, and SD.
Code Information
Lot Number: 128361; UDI: 00810012480277