Ossur recalls ReSolve Halo Vest models with incorrect titanium pin label description. This affects products made from June 30, 2009 to December 13, 2018. Correct label description is critical for MRI safety.
Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label mistakenly lists ceramic tip. The second line description should state titanium pin.
Ossur is recalling specific ReSolve Halo Vest models due to a label error on the titanium pin description. This error could lead to incorrect MRI safety labeling, potentially causing issues during MRI scans if the device is not properly labeled.
The titanium pin label incorrectly states 'ceramic tip' instead of 'titanium pin'. This error could cause the device to be mislabeled as MRI-safe when it isn't, leading to safety risks during MRI procedures.
People with Ossur ReSolve Halo Vest models made between June 30, 2009 and December 13, 2018 are affected. Those who use these vests for MRI scans are most at risk due to potential labeling errors.
Check for model numbers 545700K, 545700L, 545800K, or 545800L on the ReSolve Halo Vest. These products were manufactured between June 30, 2009 and December 13, 2018.
Look for the second line on the titanium pin label to confirm it states 'titanium pin' instead of 'ceramic tip'.
The recall is due to a label error where the titanium pin description mistakenly lists 'ceramic tip' instead of 'titanium pin'. This could lead to incorrect MRI safety labeling.
Models 545700K, 545700L, 545800K, and 545800L were manufactured between June 30, 2009 and December 13, 2018.
No, but you should check the label description to ensure it correctly states 'titanium pin' for MRI safety.
We’ve drafted a message you can send Ossur to request your refund or repair — edit it as you like.
Subject: Recall Z-1003-2019 — Ossur Ossur Hello, I own a Ossur that is covered by recall Z-1003-2019 from Ossur. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
