Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MD, Part ID 16814
Check against the official notice below — it lists the full affected range.
The BioPro, Inc. Titanium MPJ (Toe Implant) has been recalled due to incorrect information in the product's instruction manual (IFU BP102303 rev 05) and patient implant cards (22266 rev 00). These materials incorrectly state that the titanium version of the implant has been tested for safety and compatibility in MRI (magnetic resonance imaging) environments and is MR Conditional. In reality, MR testing has not been conducted on the titanium version of this implant. The recall affects products distributed nationwide in Connecticut, Kentucky, New Mexico, Pennsylvania, Tennessee, and South Dakota, specifically Lot Numbers 125423 and 128356.
The source document does not specify a remedy 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: 125423, 128356; UDI: 00810012480093
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.