# FDA recall Z-1856-2025

> **Prismatik Dentalcraft, Inc.** · Class II · device recall initiated 2025-04-14.

## 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 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.

## Reason for recall

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

## Distribution

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

## Key facts

- **Recall number:** Z-1856-2025
- **Recalling firm:** Prismatik Dentalcraft, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-04-14
- **Report date:** 2025-06-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irvine, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1856-2025

## Citation

> AI Analytics. FDA recall Z-1856-2025. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1856-2025. Source: US FDA. Licensed CC0.

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