NobelReplace Conical Connection (CC) PMC RP 4.3x10mm implants may cause nerve damage if incorrectly measured. Recalled due to label error showing 5.0x8mm instead of actual 4.3x10mm.
Dental implant cap label may incorrectly indicate implant measurements 5.0x8mm. Actual implant measurements are 4.3x10mm. If not noticed prior to implant placement, this could lead to: 1) A second surgical procedure; 2) Implant replacement; 3) If placed in posterior lower jaw, the implant may damage the inferior alveolar nerve canal or perforate a small artery requiring immediate implant removal.
NobelReplace Conical Connection implants (4.3x10mm) are recalled because their labels incorrectly show 5.0x8mm measurements. If not noticed before implant placement, this could require additional surgery, implant replacement, or damage to the nerve canal in the lower jaw.
The implant label shows 5.0x8mm instead of the actual 4.3x10mm size. If the incorrect size is used in the lower jaw, it could damage the nerve canal or small blood vessels, requiring immediate removal.
Dental patients who received NobelReplace Conical Connection implants (4.3x10mm) during procedures between specific dates. Those with implants in the lower jaw are at higher risk of nerve damage.
Check for the label showing 5.0x8mm instead of 4.3x10mm. The product was sold with lot number 13084072 and UDI code (01)07332747073584(10)13084072(17)240525.
Look for the label showing 5.0x8mm instead of the correct 4.3x10mm measurement.
The label incorrectly shows 5.0x8mm measurements instead of the actual 4.3x10mm size, which could lead to nerve damage or surgery if not noticed before implant placement.
Check the implant label for 5.0x8mm instead of 4.3x10mm. If you have the incorrect size, contact your dentist for further guidance.
Yes, if the implant is placed in the lower jaw, it could damage the nerve canal or small blood vessels, requiring immediate removal.
We’ve drafted a message you can send NobelReplace to request your refund or repair — edit it as you like.
Subject: Recall Z-2828-2020 — NobelReplace NobelReplace Hello, I own a NobelReplace that is covered by recall Z-2828-2020 from NobelReplace. 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.