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

NobelReplace CC PMC NP 3.5x13mm, Article No. 37288. — recall Z-1436-2015

U.S. FDA — Device Enforcement · United States · 2015-03-09 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1436-2015
Date of alert
2015-03-09
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)
13010297
Reported risk: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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.