Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 16813
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 instructions for use and patient implant cards. The documentation states that the implant has been tested for safety and compatibility in MRI environments and is "MR Conditional," but MRI testing has not actually been performed on the titanium version of this implant. The affected product includes Lot Number 128667 with UDI 00810012480086, and was distributed nationwide across Connecticut, Kentucky, New Mexico, Pennsylvania, Tennessee, and South Dakota.
Consumers who received this implant should be aware that the MRI safety claims in their documentation may be inaccurate. The recall record does not specify what remedy or action affected consumers should 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: 128667; UDI: 00810012480086
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.