The Recall Desk
HighFDA (Devices)·Z-1856-2025·Announced 2025-06-04

[pending] Glidewell HT Implant Twist Drill ¿1.5 x 8 mm " SKU # 70-1071-SRG0266 UDI code: +D7457071SRG02660/$$

Pending LLM rewrite. Source: FDA_DEVICE Z-1856-2025.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

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

The recalled product

Product
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
Manufacturer
Prismatik Dentalcraft, Inc.

Distribution

Distributed nationwide across the United States.