Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2207-2020 — NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, Sterile R, CE, UDI: (01)07332747010619

U.S. FDA — Device Enforcement · United States · 2019-07-19 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2207-2020
Date of alert
2019-07-19
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Nobel Biocare Usa Llc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
13080792
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.