BioPro recalls Titanium MPJ toe implants (Part ID 17035) due to unverified MR compatibility claims. Patients may face risks during MRI scans if the implant is not properly tested for safety in magnetic fields.
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 safety in MRI machines. This means patients with these implants could face risks during MRI scans if the implant isn't properly checked for compatibility.
The implant's instructions claim it's safe for MRI scans, but it hasn't been tested for safety in magnetic fields. This could cause issues during MRI procedures if the implant isn't properly checked for compatibility.
Patients with the recalled titanium toe implants (Part ID 17035) who may need MRI scans. Those with the specific lot numbers 124735, 128448, or 126522 are most at risk.
Check for the part ID 17035 on the implant. Look for lot numbers 124735, 128448, or 126522. The unique device identifier (UDI) starts with 00810012480239.
Review the implant's part ID, lot number, and UDI to confirm if it matches the recalled items.
The implant's instructions claim it's safe for MRI scans, but it hasn't been tested for safety in magnetic fields.
Check the implant's part ID, lot number, and UDI to see if it matches the recalled items. If it does, contact BioPro for guidance.
No, the implant hasn't been tested for safety in MRI machines, so patients should avoid MRI scans without proper verification.
We’ve drafted a message you can send BioPro to request your refund or repair — edit it as you like.
Subject: Recall Z-0686-2022 — BioPro BioPro Hello, I own a BioPro that is covered by recall Z-0686-2022 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.
