Prismatik Dentalcraft, Inc.: Device Recall

Recall #Z-1856-2025 · 04/14/2025

Class II: Risk

Recall Details

Recall Number
Z-1856-2025
Classification
Class II
Product Type
Device
Recalling Firm
Prismatik Dentalcraft, Inc.
Status
Ongoing
Date Initiated
04/14/2025
Location
Irvine, CA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
15 units

Reason for Recall

Due to packaging mix up. Package of finished devices were reported to have an incorrect finished device package inside.

Product Description

Glidewell HT Implant Twist Drill ¿1.5 x 8 mm " SKU # 70-1071-SRG0266 UDI code: +D7457071SRG02660/$$76254798/16D20250219V The Glidewell HT" Implant Twist Drill is indicated to prepare the site for placement of endosseous dental implants when tissue contact will last less than 1 hour. The Glidewell HT" Implant Twist Drill is used to remove bone from osteotomy during dental implant placement. The initial Twist Drill is used to deepen the osteotomy and establish the trajectory of subsequent drills in the placement of a dental implant. The large Twist Drill is stepped to accmmodate the tapered design of the implant and is available in lengths corresponding to the availble implant lengths. Drill length is calculated to indicate where the top of the implant will reside when fully seated to that depth. The Twist Drill is machined from stainless steel.

Distribution Pattern

U.S Nationwide distribution in the states of KY, MA, MI, NC, VA, and WV.

Other Recalls by Prismatik Dentalcraft, Inc.

View all recalls by Prismatik Dentalcraft, Inc. →

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.