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

Recall Z-1511-2015 — TS ROC Crown Component 4UR (5/pk), TS ROC Crown Component 5UR (5/pk), TS ROC Crown Component 6UR (5/pk), TS ROC Crown Component 7UR (5/pk), TS ROC Crown Component 8UR (5/pk), TS ROC Crown Component 4LR (5/pk), TS ROC Crown Component 5LR (5/pk), TS ROC Crown Component 6LR (5/pk), TS ROC Crown Compone

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-1511-2015
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

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