BioPro recalls Titanium MPJ toe implants due to unverified MR compatibility claims. The implant may not be safe for MRI scans as testing was not done on the titanium version.
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 device is not properly checked.
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 was done on the titanium version, so it could cause injury during MRI procedures.
Patients with the recalled titanium toe implant (Part ID 16815) who undergo MRI scans are at risk. Those who have the implant but don't know it's recalled may not be aware of the danger.
Check for the Part ID 16815 on the implant. The lot numbers 124738 and 127602 are also associated with this recall. The implant is used in toe joints and is made of titanium.
If you have this implant and plan to undergo an MRI, consult your doctor about the risks before proceeding.
The recall states that the titanium version has not been tested for MRI safety, so it may not be safe. The product manual incorrectly claims it is MR Conditional.
Look for the Part ID 16815 on the implant, or check if your implant has lot numbers 124738 or 127602.
Contact BioPro directly to confirm if your implant is recalled and discuss MRI safety with your doctor.
We’ve drafted a message you can send BioPro to request your refund or repair — edit it as you like.
Subject: Recall Z-0684-2022 — BioPro BioPro Hello, I own a BioPro that is covered by recall Z-0684-2022 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.
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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.
