BioPro recalls Titanium MPJ toe implants due to unverified MRI safety 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 its Titanium MPJ toe implants because they haven't been tested for MRI safety. This means patients could face risks if they get an MRI scan without knowing the implant might not be safe.
The implant's user manual and patient cards incorrectly state it's MRI safe (MR Conditional). However, no MRI safety testing was done on the titanium version, so it could be unsafe during MRI scans.
Patients with the recalled Titanium MPJ toe implants are most at risk if they need MRI scans. The recall affects individuals who received this specific implant model.
Check for the part ID 168816 on the implant. The recall includes lot numbers 125672 and 128357. This implant is used for toe joints.
Look for the part ID 16816 on the implant and check the lot numbers 125672 or 128357.
The implant's user manual and patient cards incorrectly state it's MRI safe, but no MRI safety testing was done on the titanium version.
The recall states that MRI safety testing was not conducted on the titanium version, so it may not be safe for MRI scans.
Check for the part ID 16816 and lot numbers 125672 or 128357 on the implant.
We’ve drafted a message you can send BioPro to request your refund or repair — edit it as you like.
Subject: Recall Z-0685-2022 — BioPro BioPro Hello, I own a BioPro that is covered by recall Z-0685-2022 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.
