Avex CX Suite, Avex CX 0.22 UL4,5 HK REF #224-017, Product Usage: Avex CX ceramic brackets are formed with 99.9% pure alumina oxide. The indicated use of the Avex CX ceramic bracket is the mechanical movement of natural teeth in conjunction with other components designed to attach to the brackets.
FDA Recall Z-0876-2013 · Posted 2013-02-22
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Recalling FirmUltradent Products, Inc.
Recall StatusTerminated
Product CodeEJF
Date Initiated2013-02-08
Date Terminated2013-06-07
Product Quantity124
Reason for Recall
Orthodontic brackets distributed was incorrectly labeled.
Firm Action
Ultradent Products, Inc. sent an Urgent Medical Device Correction letter dated February 8 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were asked to return affected products for replacement. Customers with questions can call firm representative, Corey Jaseph at (801) 553-4220.
Root Cause
Packaging
Distribution Pattern
USA Nationwide Distribution including the states of CA, AZ, CO and WA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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