Recall Z-1856-2025— Prismatik Dentalcraft, Inc.

Class II FDA medical device recall by Prismatik Dentalcraft, Inc., initiated 2025-04-14. FDA's recall record names no specific 510(k) clearance for this event. 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: Due to packaging mix up. Package of finished devices were reported to have an incorrect finished device package inside..

Recalling firm

Prismatik Dentalcraft, Inc.

Classification

Class II

Status

Ongoing

Initiated

2025-04-14

Firm location

Irvine, CA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.