BioPro recalls Titanium MPJ toe implants (Part ID 16814) due to unverified MR safety claims. Patients may face risks during MRI scans if the implant is not properly tested for compatibility.
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.
BioPro is recalling a specific titanium toe implant model because it hasn't been tested for MRI safety. This means patients with this implant could face risks during MRI scans if the implant isn't properly checked for compatibility.
The implant's user manual and patient cards incorrectly state it's MR Conditional, meaning it's safe for MRI scans. However, no actual MR testing has been done on the titanium version, so it could cause issues during MRI procedures.
Patients who have received the Titanium MPJ toe implant (Part ID 16814) are most at risk. This recall affects individuals who may need MRI scans without knowing the implant's safety status.
Check for the part ID 16814 on the implant or patient card. The lot numbers 125423 and 128356 are also associated with this recall.
Review the implant's user manual (IFU BP102303 rev 05) and patient card (22266 rev 00) for the part ID 16814.
The recall states that MR testing has not been conducted on this titanium version, so it may not be safe for MRI scans.
The recall does not specify a remedy, so contact BioPro directly for guidance.
Look for part ID 16814 on the implant or patient card, or lot numbers 125423 or 128356.
We’ve drafted a message you can send BioPro to request your refund or repair — edit it as you like.
Subject: Recall Z-0683-2022 — BioPro BioPro Hello, I own a BioPro that is covered by recall Z-0683-2022 from BioPro. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
