Device product
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
Z-0417-2026
Product summary
- Event
- Event 97720
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 208 units
- Official record key
device-enforcement:Z-0417-2026
Official wording
Reason: Incorrect titanium screw, packaged with dental implant.
Code information: Lot Code: Product Catalog Number (SKU#): 70-1047-COM0117 UDI: +D745701047COM01170/$$80176270484/16D20250722E Lot Number: 6270484, 6271089
Distribution pattern: 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.
Derived failure modes
-
Unknown
Incorrect titanium screw, packaged with dental implant.