BioPro recalls certain titanium toe implants due to unverified MRI safety claims. The implants 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 specific titanium toe implants because they haven't been tested for MRI safety. This means patients with these implants could face risks during MRI scans if the device is not properly checked.
The implants were incorrectly labeled as MRI-safe (MR Conditional) in their instructions and patient cards, but no actual MRI testing was done on the titanium version. This means MRI scans could be unsafe for patients with these implants.
Patients with the recalled titanium toe implants are most at risk. The recall affects individuals who have received the specific implant model with Part ID 17036.
Check for Part ID 17036 on the implant. The recall includes specific lot numbers: 127603 and 125590. The implant is a titanium toe joint device.
Verify if your implant has been tested for MRI safety by contacting BioPro directly.
The implant was incorrectly labeled as MRI-safe in its instructions and patient cards, but no MRI testing was done on the titanium version.
No, but you should check with BioPro before undergoing any MRI scans.
Contact BioPro to confirm if your implant is part of the recall and discuss MRI safety options.
We’ve drafted a message you can send BioPro to request your refund or repair — edit it as you like.
Subject: Recall Z-0687-2022 — BioPro BioPro Hello, I own a BioPro that is covered by recall Z-0687-2022 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.
