Ossur recalls specific skull pins due to a label error listing ceramic tip instead of titanium. Affected products were sold from June 2009 to December 2018. Correct label should state titanium pin.
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 skull pins that have a label error showing a ceramic tip instead of titanium. This mistake could confuse users about the pin's material, but it does not pose a safety risk.
The label incorrectly states the pin has a ceramic tip instead of titanium. This could lead to misunderstandings about the pin's material, but the product itself is safe and does not cause injury.
Patients using Ossur skull pins for medical implants. Those with the specific part numbers and production dates listed are most at risk of confusion about the pin's material.
Check for part numbers 516TS, 520TS, 516V2S, or 520V2S with production dates from June 30, 2009, to December 13, 2018. The label should correctly state 'titanium pin' instead of 'ceramic tip'.
Look for the label that says 'titanium pin' instead of 'ceramic tip' on the product.
The label mistakenly lists ceramic tip instead of titanium. This is a labeling error, not a safety hazard.
No, the pins are safe but the label error could cause confusion about the material. There is no need to stop using them.
Part numbers 516TS, 520TS, 516V2S, 520V2S with production dates from June 30, 2009, to December 13, 2018.
We’ve drafted a message you can send Ossur to request your refund or repair — edit it as you like.
Subject: Recall Z-0997-2019 — Ossur Ossur Hello, I own a Ossur that is covered by recall Z-0997-2019 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.
