Prismatik Dentalcraft, Inc.: 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.

Details from the source

Reason for recall: Incorrect titanium screw, packaged with dental implant. Distribution: 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. Quantity: 208 units Lot/code info: Lot Code: Product Catalog Number (SKU#): 70-1047-COM0117 UDI: +D745701047COM01170/$$80176270484/16D20250722E Lot Number: 6270484, 6271089

UPC codes

80176270484

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.