BioPro recalls Titanium MPJ toe implants due to unverified MRI safety claims. The titanium version hasn't been tested for MR compatibility, risking unsafe 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 a specific titanium toe implant model because it hasn't been tested for MRI safety. This means patients could face unsafe MRI scans if they have this implant.
The implant's documentation incorrectly states it's safe for MRI use. But titanium implants haven't been tested for MRI safety, so scans could cause harm.
Patients with the recalled titanium toe implant who undergo MRI scans are at risk. Those without the implant are not affected.
Check for the part ID 17197 on the implant. The lot number 128361 and UDI 00810012480277 are also associated with this recall.
If you have this implant and need an MRI, consult your doctor about alternative imaging options.
The recall states the titanium version hasn't been tested for MRI safety, so it's not safe for MRI scans.
Look for part ID 17197, lot number 128361, or UDI 00810012480277 on the implant.
Contact BioPro for guidance on MRI safety alternatives if you need scans.
We’ve drafted a message you can send BioPro to request your refund or repair — edit it as you like.
Subject: Recall Z-0690-2022 — BioPro BioPro Hello, I own a BioPro that is covered by recall Z-0690-2022 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.
