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

Recall Z-0583-2016 — InterGuard 5.5mm Econo Refill, sizes, 4.0mm for short anatomical crowns and 5.5mm, part # 4012 Product Usage: InterGuard is a preventive aid for operative dentistry. It is used to protect adjacent teeth from iatrogenic preparation damage. This includes cavity and tunnel preparations as well as

U.S. FDA — Device Enforcement · United States · 2015-12-22 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0583-2016
Date of alert: 2015-12-22
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Ultradent Products, Inc.
Product category: device
Product type: Devices

Reported risk: Ultradent is recalling InterGuard 5.5mm Econo Refill, lot#s BC2GN and BC4L7 because product was received from the supplier with the floss tether hole not completely punched through and were distributed.

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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