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