FDA-Device2025-11-12Class IIPACKAGING DEFECT
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
Hazard
Incorrect titanium screw, packaged with dental implant.
Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
208 units
Manufactured in
2144 Michelson Dr, N/A, Irvine, CA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0417-2026More Prismatik Dentalcraft recalls
- FDA-Device2026-07-29Silent Nite Sleep Appliance recalled — device lacks FDA clearance
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