Ossur recalls specific ring kits due to incorrect titanium pin labeling. Products labeled MR conditional may need safety testing. Affected items were sold from June 2009 to December 2018.
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 ring kits that have incorrect labeling on the titanium pins. This could lead to safety issues if the products are used without proper verification.
The titanium pin labels mistakenly list ceramic instead of titanium. This could cause safety issues if the products are used without proper verification. The recall involves products that were labeled as MR conditional but need confirmatory safety testing.
People who own or use Ossur ring kits with the specific model numbers listed in the recall. Those with medical implants requiring these kits are most at risk.
Check for model numbers like 505300T, 505300V2, or 505400T on the ring kits. Products were sold between June 30, 2009, and December 13, 2018.
Look for model numbers such as 505300T, 505300V2, or 505400T on the ring kits.
Ensure the titanium pin label correctly states 'titanium pin' instead of 'ceramic tip' as per the recall.
Models include 505300T, 505300V2, 505400T, 505400V2, 505500T, 505500V2, 515300V2, 515400V2, 515500T, 515500V2, 515300T, 515400T, 515301T, 515301V2, 515401T, 515401V2, 515501T, 515501V2, 540T, and 540V2.
Products were sold from June 30, 2009, to December 13, 2018.
No, the recall does not require immediate stop use. The products need verification of labeling and safety testing.
We’ve drafted a message you can send Ossur to request your refund or repair — edit it as you like.
Subject: Recall Z-1001-2019 — Ossur Ossur Hello, I own a Ossur that is covered by recall Z-1001-2019 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.
