Prismatik Dentalcraft, Inc.: Device Recall
Recall #Z-0417-2026 · 09/30/2025
Class II: Risk
Recall Details
- Recall Number
- Z-0417-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Prismatik Dentalcraft, Inc.
- Status
- Ongoing
- Date Initiated
- 09/30/2025
- Location
- Irvine, CA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 208 units
Reason for Recall
Incorrect titanium screw, packaged with dental implant.
Product Description
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
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.
Other Recalls by Prismatik Dentalcraft, Inc.
- Class II: Risk 04/14/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.