Z-0053-2021 Class II Terminated
FDA device recall Z-0053-2021 was initiated by Ultradent Products, Inc. on August 31, 2020 and is designated Class II. Reason for recall: Due to a potential manufacturing issue (cross contamination), composite is non-homogeneous. The recall status is terminated (terminated October 18, 2021). Affected quantity: 412 syringes (206 kits).
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