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

Recall Z-0535-2014 — 3M ESPE Imprint II Regular Body , Catalog Number 9379, and Paradigm Regular Body VPS, Catalog Number 5315, Impression Material that are intended to reproduce the structure of a patients teeth. Impression Materials are composed of hydrophilic vinyl polysiloxane impression materials, designed for m

U.S. FDA — Device Enforcement · United States · 2013-11-21 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0535-2014
Date of alert: 2013-11-21
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: 3M Company - Health Care Business
Product category: device
Product type: Devices

Reported risk: Specific lots of Imprint II and Paradigm impression material refill packs are being recalled because the moisture displacement feature in both is greatly reduced which may impact the quality of the dental impression.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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.

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