BioPro recalls Titanium MPJ toe implants due to unverified MR 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 a specific titanium toe implant model because it hasn't been tested for MRI safety. This means patients could face risks if they undergo MRI scans without knowing the implant's compatibility.
The implant's instructions claim it's MR Conditional, but testing was never done on the titanium version. This means it might not be safe during MRI scans, potentially causing harm if scanned without proper safety checks.
Patients with the recalled titanium toe implant are most at risk if they need MRI scans. The recall affects individuals who received this specific implant model from BioPro.
Check for the part ID 17037 on the implant. The recall includes specific lot numbers: 124737 and 125470. This implant is used for toe joints and has a unique UDI code M20917037.
Look for the part ID 17037 and lot numbers 124737 or 125470 on the implant.
The recall states that testing was not done on the titanium version, so it may not be safe for MRI scans. Patients should consult their doctor before undergoing MRI.
Check for part ID 17037 and lot numbers 124737 or 125470 on the implant. The UDI code M20917037 is also associated with this model.
The recall does not specify a remedy, so contact BioPro directly for guidance on next steps.
We’ve drafted a message you can send BioPro to request your refund or repair — edit it as you like.
Subject: Recall Z-0688-2022 — BioPro BioPro Hello, I own a BioPro that is covered by recall Z-0688-2022 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.
