Titanium MPJ (Toe Implant)TOE JOINT TITANIUM NPC LG, Part ID 16816
Check against the official notice below — it lists the full affected range.
BioPro, Inc. is recalling the Titanium MPJ (Toe Implant) due to an incorrect statement in the product's instructions for use and patient implant cards. The documentation claims the implant has been tested for safety and compatibility in MR (magnetic resonance) environments and is MR Conditional, but MR testing has not actually been conducted on the titanium version of this implant. The affected product includes Lot Numbers 125672 and 128357, and the recall affects patients in Connecticut, Kentucky, New Mexico, Pennsylvania, Tennessee, and South Dakota.
The source document does not specify a remedy or action for affected consumers to take.
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: 125672, 128357; UDI: 00810012480116
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.