Nobel Biocare recalls 3.5x15mm Endosseus dental implants with potentially incorrect length labels that could cause nerve damage or extra surgery.
The top label for dental implant may incorrectly indicate the implant length. Specifically, the label may contain 11.5mm for the length, which is shorter than the actual length of the implant (15mm). An incorrect sized implant may cause patient discomfort, permanent nerve damage and may require an additional surgery.
Nobel Biocare is recalling dental implants that may have labels showing a shorter length than actual. This could lead to patient discomfort, nerve damage, or needing additional surgery.
The implant label might show 11.5mm instead of the actual 15mm length. Using an implant that's too short could cause improper fit, leading to discomfort, nerve damage, or requiring extra surgery.
Dental patients who received this specific implant model (3.5x15mm Endosseus) from a dentist. Patients with the implant may be at risk of discomfort or nerve damage.
Check for the implant model '3.5x15mm Endosseus' with reference number 34128. The implant was sold with a unique identifier (UDI) starting with (01)07332747010619.
Look for the label indicating the implant length; it should be 15mm, not 11.5mm.
The label may incorrectly show 11.5mm instead of 15mm, which could cause discomfort, nerve damage, or extra surgery.
Check for the model '3.5x15mm Endosseus' with reference number 34128 and unique identifier starting with (01)07332747010619.
The recall doesn't specify a remedy, so you should check the label to ensure it shows 15mm length. Contact your dentist if you're unsure.
We’ve drafted a message you can send Nobel Biocare to request your refund or repair — edit it as you like.
Subject: Recall Z-2207-2020 — Nobel Biocare Nobel Biocare Hello, I own a Nobel Biocare that is covered by recall Z-2207-2020 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.
