Ossur recalls skull pins with incorrect ceramic tip labeling. Products manufactured between June 2009 and December 2018 may have a label error that could affect 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 skull pins that have a label error listing 'ceramic tip' instead of 'titanium pin'. This could cause MRI safety issues if the product is used in MRI environments. Affected products were made between June 2009 and December 2018.
The label mistakenly lists 'ceramic tip' instead of 'titanium pin'. This could cause MRI safety issues if the product is used in MRI environments, as ceramic materials may not be safe for MRI scans.
People who own or use Ossur skull pins made between June 2009 and December 2018 are affected. Those using these pins for MRI scans are at higher risk due to potential labeling errors.
Check for skull pins with part numbers 516CS, 516DS, 517CS, 517DS, 522CS, or 522C manufactured between June 30, 2009 and December 13, 2018.
Look for the label that states 'ceramic tip' instead of 'titanium pin' on the product.
The recall is happening because the label mistakenly lists 'ceramic tip' instead of 'titanium pin', which could cause MRI safety issues.
Skull pins with part numbers 516CS, 516DS, 517CS, 517DS, 522CS, or 522C manufactured between June 30, 2009 and December 13, 2018.
Check the label for the correct material description. If it says 'ceramic tip', contact Ossur for further instructions.
We’ve drafted a message you can send Ossur to request your refund or repair — edit it as you like.
Subject: Recall Z-0998-2019 — Ossur Ossur Hello, I own a Ossur that is covered by recall Z-0998-2019 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.
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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.
