Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MS, Part ID 17197
Check against the official notice below — it lists the full affected range.
BioPro, Inc. is recalling the Titanium MPJ (toe joint implant), Part ID 17197, due to incorrect information in the implant's instruction manual and patient cards. The materials state that the 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 implant. The affected product is Lot Number 128361 with UDI 00810012480277, and it was distributed nationwide in Connecticut, Kentucky, New Mexico, Pennsylvania, Tennessee, and South Dakota.
The recall addresses a potential safety concern for patients who might undergo MRI procedures based on the false compatibility information. The source document 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: 128361; UDI: 00810012480277
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.