BioPro recalls titanium 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 a specific titanium toe implant model because it hasn't been tested for MRI safety. This means patients with this implant could face risks if they undergo MRI scans without proper precautions.
The implant's instructions falsely claim it's MRI-safe (MR Conditional) when no actual MRI testing was done on the titanium version. This could lead to serious complications like tissue damage during an MRI scan if the implant is not properly checked.
Patients who have received the titanium toe implant (part ID 17198) are most at risk. This recall affects individuals who may need MRI scans in the future.
Check for the part ID 17198 on the implant or patient card. The implant was sold with lot number 125651 and UDI M20917198.
Verify if your implant has been tested for MRI safety by consulting your healthcare provider or the manufacturer.
The recall states that MRI testing was not conducted on the titanium version, so it may not be safe for MRI scans.
Look for part ID 17198 on the implant or patient card, with lot number 125651 and UDI M20917198.
Consult your healthcare provider to determine if MRI scans are safe and discuss alternative imaging options.
We’ve drafted a message you can send BioPro to request your refund or repair — edit it as you like.
Subject: Recall Z-0691-2022 — BioPro BioPro Hello, I own a BioPro that is covered by recall Z-0691-2022 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.
