Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC ML, Part ID 16815
Check against the official notice below — it lists the full affected range.
BioPro, Inc. is recalling the Titanium MPJ (toe implant) due to incorrect statements in the implant's instructions for use and patient implant cards. The documentation states that the BioPro titanium toe implant has been tested for safety and compatibility in MRI environments and is MR Conditional, but MRI testing has not actually been conducted on the titanium version of this device. The affected implants were distributed nationwide in Connecticut, Kentucky, New Mexico, Pennsylvania, Tennessee, and South Dakota, with specific lot numbers 124738 and 127602.
Patients who received this implant should be aware that they cannot rely on the MR Conditional designation provided in their documentation. The recall source 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: 124738, 127602; UDI: 00810012480109
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.