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

Recall Z-1506-2015 — M-4 Mechanism Set 16 mm and M-4 Mechanism Set 19 mm 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-1506-2015
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.

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