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BioPro, Inc. recalls Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MS, Part ID 17198
Recalled March 9, 2022 · FDA recall Z-0691-2022 · BioPro
Hazard
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. · FDA Class II
Sold at
US Nationwide distribution in the states of CT, KY, NM, PA, TN, and SD.
Description
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
Manufacturer(s)
BioPro, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →