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Recall Observatory FDA recall evidence

Device product

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.

Z-0053-2021

August 31, 2020

Class II

Product summary

Firm
Ultradent Products, Inc.
Event
Event 86432
Status
Terminated
Classification
Class II
Quantity
412 syringes (206 kits)
Official record key
device-enforcement:Z-0053-2021

Official wording

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

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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