Titanium MPJ (Toe Implant)TOE JOINT TITANIUM PC SM, Part ID 17035
Check against the official notice below — it lists the full affected range.
BioPro, Inc. is recalling the Titanium MPJ (toe joint implant), Part ID 17035, because documentation provided with the implant contains incorrect information about magnetic resonance (MR) compatibility. The implant's instructions for use (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) state that the titanium version has been tested for safety and compatibility in MR environments and is MR Conditional. However, MR testing has not actually been conducted on the titanium version of this implant. The affected implants were distributed nationwide in Connecticut, Kentucky, New Mexico, Pennsylvania, Tennessee, and South Dakota, with lot numbers 124735, 128448, and 126522.
The recall record does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Lot/code info: Lot Number: 124735, 128448, 126522; UDI: 00810012480239
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.