Class II — Prismatik Dentalcraft, Inc.
| Recalling firm | PRISMATIK DENTALCRAFT, INC. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Incorrect titanium screw, packaged with dental implant. |
| 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 |
| Quantity | 208 units |
| 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. |
| Initiated | 2025-09-30 |
| Classified | 2025-11-03 |
| Recall number | Z-0417-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Prismatik Dentalcraft, Inc. (Z-0417-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97720/
Alerts for PRISMATIK DENTALCRAFT, INC.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.