Prismatik Dentalcraft, Inc. recalls Glidewell HT Implant Twist Drill ¿1.5 x 8 mm " SKU # 70-1071-SRG0266 UDI code: +D7457071SRG02660/$$76254798/16D20250219…

Recall date

April 14, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1856-2025

FDA classification

Class II

Brand / firm

Prismatik Dentalcraft, Inc.

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.