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

Recall Z-1505-2015 — Specialty MiniScope Mech. Set Size 18, Specialty MiniScope Mech. Set Size 21, and Specialty MiniScope Mech. Set Size 24 A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance.

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-1505-2015
Date of alert: 2015-03-09
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Specialty Appliance Works, Inc.
Product category: device
Product type: Devices

Reported risk: The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.

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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