Almore International Inc recalls Microfil Composite Instruments are packaged in an unsealed plastic sleeve, which is then placed in a cardboard box. Mic…

Recall date

April 20, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2069-2017

FDA classification

Class II

Brand / firm

Almore International Inc

Sold / distributed

Worldwide distributed - US Nationwide in AZ, CA, CO, CT, FL, GA, IA, IL, IN, MA, MN, MO, NC, NJ, NV, NY, OH, PA, TN, TX, WA, and WI, and internationally in Canada, Netherlands, and South Korea.

Why it was recalled

Microfil Composite Instruments were distributed with a sterile symbol on their packaging label inserts, indicating that the products are sold as sterile devices. These products are not sterile and they are intended to be sterile prior to each use.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Microfil Composite Instruments are packaged in an unsealed plastic sleeve, which is then placed in a cardboard box. Microfil Composite Instruments are intended to be sterilized by the dentist prior to each use. It is used for composite restoration development. The thin paddles shape light-cured composites. Paddles slide under the gum line to shape the margin. The flat ends contour the surfaces of the teeth and the thin edge is used to create esthetic highlights. Models: #96041  Gold Microfil #96042  Green Microfil #96043  Blue Microfil #96044  Set of 3 Microfil (Gold, Green, Blue)