FDA recall Z-0686-2022

Product

Titanium MPJ (Toe Implant)TOE JOINT TITANIUM PC SM, Part ID 17035

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

US Nationwide distribution in the states of CT, KY, NM, PA, TN, and SD.

Key facts

Status

Terminated

Initiation date

2022-02-01

Report date

2022-03-09

Termination date

2024-02-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Port Huron, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0686-2022