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 because it hasn't been tested for safety in MRI environments. This means patients with this implant could face risks during MRI scans if the device is not properly checked.
The implant's documentation incorrectly states it's MR Conditional, but no actual MRI testing was done on the titanium version. This means it might not be safe during MRI scans, potentially causing harm if scanned without proper checks.
Patients with the recalled titanium toe implant are most at risk. This affects individuals who have undergone surgery with this specific implant model.
Check for the part ID 16813, lot number 128667, or UDI 00810012480086 on the implant. The product is sold under BioPro, Inc. as a titanium toe implant.
Review the implant's patient card or IFU for the part ID, lot number, or UDI to confirm if it's recalled.
The recall states that MRI testing was not done on the titanium version, so it may not be safe. Patients should consult their doctor before any MRI scans.
Look for part ID 16813, lot number 128667, or UDI 00810012480086 on the implant.
Check the implant documentation to confirm if it's recalled. If it is, consult your doctor about MRI safety before any scans.
We’ve drafted a message you can send BioPro to request your refund or repair — edit it as you like.
Subject: Recall Z-0682-2022 — BioPro BioPro Hello, I own a BioPro that is covered by recall Z-0682-2022 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.
