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

Recall Z-1854-2020 — Esthetic Abutment CC RP 1.5 mm pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36669 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function.

U.S. FDA — Device Enforcement · United States · 2019-08-09 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1854-2020
Date of alert
2019-08-09
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)
13077560
Reported risk: Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightened with the correct screw.
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.