Ossur recalls specific halo system products from 2009-2018 due to incorrect titanium pin labeling. This labeling error may cause confusion during medical use.
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 certain halo system products made between June 2009 and December 2018 because the titanium pin labels incorrectly list ceramic tips instead of titanium. This labeling error could lead to confusion during medical procedures.
The titanium pin labels on these products mistakenly list ceramic tips instead of titanium. This error could cause confusion during medical procedures, potentially affecting treatment outcomes. However, the products themselves are not defective and do not pose an immediate safety risk.
Patients using Ossur halo system products with the specific model numbers (JT-115, JT-200, JT-210, JT-400) manufactured between June 2009 and December 2018 are affected. Medical professionals who use these products are at risk of confusion during procedures.
Check for products labeled with model numbers JT-115, JT-200, JT-210, or JT-400 manufactured between June 30, 2009, and December 13, 2018. The titanium pin label should clearly state 'titanium pin' without mentioning ceramic.
Verify the titanium pin label states 'titanium pin' without mentioning ceramic tips.
The titanium pin labels on these products mistakenly list ceramic tips instead of titanium, which could cause confusion during medical procedures.
Models JT-115, JT-200, JT-210, and JT-400 manufactured between June 30, 2009, and December 13, 2018.
No, the products are not defective and do not pose an immediate safety risk. However, you should check the label to ensure it correctly states 'titanium pin'.
We’ve drafted a message you can send Ossur to request your refund or repair — edit it as you like.
Subject: Recall Z-1002-2019 — Ossur Ossur Hello, I own a Ossur that is covered by recall Z-1002-2019 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.
