Nobel Biocare recalls specific NobelReplace Conical Connection implants due to potential incorrect offset gauge during production, which may cause surgical delays or aborted procedures. Affected units have unique identifiers and lot numbers.
Due to 16 complaints related to drivers not engaging in implants. According to the firm's investigations, the incorrect offset gauge was potentially used during production of the implants. As a result, this could potentially lead to aborted or a delay in surgical procedure.
Nobel Biocare is recalling certain NobelReplace Conical Connection implants because they might have been made with the wrong offset gauge, which could lead to surgical delays or procedures being aborted. This recall affects specific model numbers and lot numbers.
The implants may have been produced with an incorrect offset gauge, which could cause the surgical procedure to be delayed or aborted. This issue arises from a potential production error that affects the implant's alignment during surgery.
Patients who received the recalled NobelReplace Conical Connection implants during surgery are affected. Surgeons and medical teams using these implants are most at risk of procedural delays.
Check for the model number 'NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707' and lot numbers 13116495, 13116496, or 13116497. The product has a unique identifier code starting with (01)07332747160529.
Verify the model number and lot numbers listed in the recall notice to confirm if your implant is affected.
The recall is due to potential incorrect offset gauge during production, which could lead to surgical delays or aborted procedures.
Check the model number and lot numbers to see if your implant is affected; the recall notice provides specific identifiers for affected units.
The recall notice does not mention a fix or remedy; affected units should be checked against the listed identifiers.
We’ve drafted a message you can send Nobel Biocare to request your refund or repair — edit it as you like.
Subject: Recall Z-0658-2022 — Nobel Biocare Nobel Biocare Hello, I own a Nobel Biocare that is covered by recall Z-0658-2022 from Nobel Biocare. 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.
