Home / Recalls / Ultradent Products, Inc. / Z-0053-2021

Z-0053-2021 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
October 14, 2020
Initiation Date
August 31, 2020
Termination Date
October 18, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
412 syringes (206 kits)

Product Description

PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product Usage: is a light cured, radiopaque, methacrylate based, flowable composite. PermaFlo contains H1¿m average particle size with narrow upper limit particle distribution.

Reason for Recall

Due to a potential manufacturing issue (cross contamination), composite is non-homogeneous.

Distribution Pattern

Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, KS, IN, LA, MA, MD, ME, MI, MT, NC, NJ, NM, NY, NV, OH, OK, PA, SC, TN, TX, UT, VT, WA, and WI. The countries of Australia, Germany Japan and Mongolia.

Code Information

Part Number - 948: PermaFlo A2 Refill Lot Number - BJR5W UPC Code - 8832505103918 UDI Code - 00883205103918

Other recalls by Ultradent Products, Inc.

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  • Z-3068-2024 Class II — Brand Name: Transcend Product Name: Transcend Singles Universal Body (UB) Refil (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-0690-2019 Class II — Enamelast Cool Mint/OT Varnish 5% NaF Mint Label Enamelast Unit Dose 200pk Co (July 12, 2018)
  • Z-3218-2017 Class II — Ultradent Products, Inc. Paper Points, Size 50 PN #1559, 200 per container, ste (August 4, 2017)
  • 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-3217-2017 Class II — Ultradent Products, Inc. Paper Points, Size 45 PN #1558, 200 per container, ste (August 4, 2017)
  • Z-3214-2017 Class II — Ultradent Products, Inc. Paper Points, Size 20 PN #1560, 200 per container, ste (August 4, 2017)