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

Recall Z-1100-2022 — Affinity Hydroactive Impression Material Heavy Body Regular Set 12PK- A vinyl poly siloxane material used to create, via impression, a reproduction of tooth and gum structure. Product ID: 013912

U.S. FDA — Device Enforcement · United States · 2022-03-18 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1100-2022
Date of alert
2022-03-18
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Clinician's Choice Dental Products Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
07540172000178
Reported risk: Wrong compression material - Template Ultra Quick matrix Material was packaged instead of the Heavy Body viscosity as indicated on the outer packaging of the 12PK
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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