Recall Z-0417-2026— Prismatik Dentalcraft, Inc.
Class II · Ongoing
Class II FDA medical device recall by Prismatik Dentalcraft, Inc., initiated 2025-09-30. It names one FDA 510(k) clearance: K142115. 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: Incorrect titanium screw, packaged with dental implant..
- Recalling firm
- Prismatik Dentalcraft, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-09-30
- Firm location
- Irvine, CA, United States
510(k) clearances named in this recall
1 on FDA's record- K142115 — INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: ZIMMER, BIOMET 3I, AND NOBEL BIOCARE IMPLANT
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
Reason for recall
Incorrect titanium screw, packaged with dental implant.
Data sourced from openFDA. This site is unofficial and independent of the FDA.