Home / Recalls / Ultradent Products, Inc. / Z-0481-2014

Z-0481-2014 Class III Terminated

Recalled by Ultradent Products, Inc. — South Jordan, UT

FDA device recall Z-0481-2014 was initiated by Ultradent Products, Inc. on November 19, 2013 and is designated Class III. Reason for recall: Ultradent Products Inc. is recalling various lots of Avex CX2 Orthodontic Brackets because the design control process was not complete prior to distribution. The recall status is terminated (terminated October 6, 2014). Affected quantity: 217 units.

Recall Details

Product Type
Devices
Report Date
December 18, 2013
Initiation Date
November 19, 2013
Termination Date
October 6, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
217 units

Product Description

Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets Avex CX2 ceramic brackets are intended for use in orthodontic treatment.

Reason for Recall

Ultradent Products Inc. is recalling various lots of Avex CX2 Orthodontic Brackets because the design control process was not complete prior to distribution.

Distribution Pattern

Nationwide Distribution including UT, CA, WA, VA, OH, and TN.

Code Information

R&D Lot Numbers:4519 - 4522, 4524 - 4527, 4530 - 4534, 4537 - 4548, 4550 - 4554, 4558 - 4612, 4618 - 4624

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  • Z-3068-2024 Class II — Brand Name: Transcend Product Name: Transcend Singles Universal Body (UB) Refil (August 2, 2024)
  • Z-3066-2024 Class II — Brand Name: Vit-l-escence Product Name: Vit-l-escence Singles A3 Model/Catalog (August 2, 2024)
  • Z-3067-2024 Class II — Brand Name: Transcend Product Name: Transcend Econo Kit (UB) - Singles Model/C (August 2, 2024)
  • Z-1368-2022 Class II — Peak Universal Bond Self-Etch Bottle Kit, Part: 4541; Peak Universal Bond Self-E (June 1, 2022)
  • Z-0053-2021 Class II — PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product Usage: is a light cur (August 31, 2020)
  • Z-0690-2019 Class II — Enamelast Cool Mint/OT Varnish 5% NaF Mint Label Enamelast Unit Dose 200pk Co (July 12, 2018)
  • Z-3216-2017 Class II — Ultradent Products, Inc. Paper Points, Size 30 PN #1555, 200 per container, ste (August 4, 2017)
  • Z-3215-2017 Class II — Ultradent Products, Inc. Paper Points, Size 25 PN #1554, 200 per container, ste (August 4, 2017)
  • Z-3218-2017 Class II — Ultradent Products, Inc. Paper Points, Size 50 PN #1559, 200 per container, ste (August 4, 2017)

FDA data resources