BioPro recalls Titanium MPJ toe implants due to unverified MR compatibility claims. The titanium version has not been tested for MRI safety, risking patient harm during scans.
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 the product's documentation incorrectly states it's safe for MRI scans. The titanium version hasn't been tested for MRI safety, which could cause harm during scans.
The implant's documentation falsely claims it's MR Conditional, meaning it's safe for MRI scans. However, the titanium version hasn't been tested for MRI safety, so it could cause injury during scans.
Patients with the recalled Titanium MPJ toe implants who undergo MRI scans are at risk. Those with the implant may need to avoid MRI scans without proper evaluation.
Check for the part ID 17038 on the implant. The recall includes specific lot numbers and UDI codes, but the record doesn't list them.
Verify if your implant is listed in the recall by checking the part ID 17038 on the device.
The documentation incorrectly states it's MR Conditional, but the titanium version hasn't been tested for MRI safety, so it may not be safe.
Check if your implant matches the recall criteria by looking for part ID 17038. Contact BioPro for guidance if you're unsure.
The recall includes part ID 17038, but the record doesn't specify lot numbers or UDI codes beyond the part ID.
We’ve drafted a message you can send BioPro to request your refund or repair — edit it as you like.
Subject: Recall Z-0689-2022 — BioPro BioPro Hello, I own a BioPro that is covered by recall Z-0689-2022 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.
