United StatesInclusive Titanium Screw compatible with Biomet 3i (brand: Inclusive) in sizes 3.4, 4.1, 5.0 and 6.0 mm, catalog number 70-1047-COM0117, lot numbers 6270484 and 6271089 (UDI +D745701047COM01170/$$80176270484/16D20250722E), distributed in several U.S. states, is affected. It was recalled because an incorrect titanium screw was packaged with a dental implant.
What's being recalled
Brand Name: Inclusive Product Name: Inclusive Titanium Screw compatible with: Biomet 3i" Certain 3.4/4.1/5.0/6.0 mm Model/Catalog Number: 70-1047-COM0117
Recalling firm: Prismatik Dentalcraft, Inc., Irvine, CA, United States.
How to identify it
Lot Code: Product Catalog Number (SKU#): 70-1047-COM0117 UDI: +D745701047COM01170/$$80176270484/16D20250722E Lot Number: 6270484, 6271089
The hazard
Incorrect titanium screw, packaged with dental implant.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Distribution to states of: California, Colorado, Connecticut, Florida, Georgia, Hawaii, Kentucky, Maryland, Massachusetts, Michigan, New Hampshire, New Jersey, New York, Pennsylvania, South Carolina, Tennessee, Virginia, Washington.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)