Ossur recalls specific OB Resolve sterile rings and kits manufactured between June 2009 and December 2018 due to incorrect labeling on titanium pins. Affected products may have safety risks if mislabeled.
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 sterile rings and kits for use with their OB Resolve system. The recall is due to incorrect labeling on the titanium pins, which could lead to safety issues if the product is used without proper identification.
The titanium pin label incorrectly lists a ceramic tip instead of titanium. This mislabeling could cause confusion during medical procedures, potentially leading to improper use or safety concerns if the product is not correctly identified.
Users of Ossur OB Resolve sterile rings and kits manufactured between June 30, 2009, and December 13, 2018 are likely affected. Patients with specific medical conditions requiring these devices may be at higher risk.
Check for the product codes 505300D, 505400D, 505500D, 515300D, 515400D, 515500D, or 540D on the Ossur OB Resolve sterile rings and kits. These items were manufactured between June 30, 2009, and December 13, 2018.
Look for the product codes listed in the recall notice to confirm if your item is affected.
The recall is due to incorrect labeling on the titanium pin, which may lead to safety issues if the product is used without proper identification.
The affected products include Ossur OB Resolve sterile rings and kits with model numbers 505300D, 505400D, 505500D, 515300D, 515400D, 515500D, and 540D, manufactured between June 30, 2009, and December 13, 2018.
No action is required beyond checking the product label to confirm if your item is affected. The recall does not require immediate discontinuation.
We’ve drafted a message you can send Ossur to request your refund or repair — edit it as you like.
Subject: Recall Z-0999-2019 — Ossur Ossur Hello, I own a Ossur that is covered by recall Z-0999-2019 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.
