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:
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Prismatik Dentalcraft, Inc.
- 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
- Reason / hazard
- Incorrect titanium screw, packaged with dental implant.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- 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.
- Recall initiated
- 2025-09-30
- Code info
- Lot Code: Product Catalog Number (SKU#): 70-1047-COM0117 UDI: +D745701047COM01170/$$80176270484/16D20250722E Lot Number: 6270484, 6271089
- Product quantity
- 208 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Irvine
- State
- CA
- Country
- United States
- Event id
- 97720
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