Reported May 17, 2017 · Terminated
Microfil Composite Instruments are packaged in an unsealed plastic sleeve, which is then placed in a cardboard box.…
Almore International Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Almore International Inc · 10950 SW 5th St Ste 270 · Beaverton, OR · 97005-4746
Is this the product you have?
- 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)
- Lot codes and dates
- no lot codes
- Amount recalled
- 1773 devices (US =1570; International = 203)
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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