Almore International Inc: Medical Device Recall in 2017 - (Recall #: Z-2069-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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)

Product Classification:

Class II

Date Initiated: April 20, 2017

Date Posted: May 17, 2017

Recall Number: Z-2069-2017

Event ID: 76963

Reason for Recall:

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.

Status: Terminated

Product Quantity: 1773 devices (US =1570; International = 203)

Code Information:

no lot codes

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated