Ossur recalls CB Resolve sterile units with incorrect titanium pin labeling. Products made between June 30, 2009 and December 13, 2018 may have ceramic tip listed instead of titanium pin. Consumers should check model numbers and contact Ossur for details.
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 CB Resolve sterile units produced between June 30, 2009 and December 13, 2018 due to incorrect labeling on the titanium pin. This labeling error could lead to confusion about the product's components, though it does not pose an immediate safety risk.
The titanium pin label incorrectly lists a ceramic tip instead of titanium. This labeling error could cause confusion about the product's components, potentially leading to incorrect usage or misunderstandings about the product's specifications. However, the error does not involve a physical hazard that could cause injury during normal use.
Users of Ossur CB Resolve sterile units with model numbers 505300C, 505400C, 505500C, 515300C, 515400C, 515500C, 540C, 553CB, 554CB, or 555CB manufactured from June 30, 2009 to December 13, 2018 are affected. Individuals using these products for medical purposes may be at risk of confusion about component specifications.
Check for model numbers 505300C, 505400C, 505500C, 515300C, 515400C, 515500C, 540C, 553CB, 554CB, or 555CB on the product. Products were manufactured between June 30, 2009 and December 13, 2018.
Identify the model number on your Ossur CB Resolve sterile unit to see if it matches the recalled list.
Reach out to Ossur directly for further assistance or to confirm if your product is affected.
The titanium pin label incorrectly lists a ceramic tip instead of titanium. This labeling error could cause confusion about the product's components.
No, the recall does not require stopping use. The error is a labeling issue that does not pose an immediate safety risk.
Check the model number and contact Ossur for details on whether your product is affected.
We’ve drafted a message you can send Ossur to request your refund or repair — edit it as you like.
Subject: Recall Z-1000-2019 — Ossur Ossur Hello, I own a Ossur that is covered by recall Z-1000-2019 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.
