FDA Medical devices recall ·
Inclusive Product Name: Inclusive Titanium Screw compatible with: Biomet… recall
- Recall number
- Z-0417-2026
- Date
- (initiated September 30, 2025)
- Company / brand
- Prismatik Dentalcraft, Inc.
2144 Michelson Dr, Irvine, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 208 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Incorrect titanium screw, packaged with dental implant.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot Code: Product Catalog Number (SKU#): 70-1047-COM0117 UDI: +D745701047COM01170/$$80176270484/16D20250722E Lot Number: 6270484, 6271089
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.
States: California Colorado Connecticut Florida Georgia Hawaii Kentucky Massachusetts Maryland Michigan New Hampshire New Jersey New York Pennsylvania South Carolina Tennessee Virginia Washington
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0417-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.