Prismatik Dentalcraft, Inc.: Medical Device Recall in 2025 - (Recall #: Z-1856-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: April 14, 2025

Date Posted: June 4, 2025

Recall Number: Z-1856-2025

Event ID: 96711

Reason for Recall:

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

Status: Ongoing

Product Quantity: 15 units

Code Information:

Glidewell HT Implant Twist Drill ¿1.5 x 8 mm SKU # 70-1071-SRG0266 UDI code: +D7457071SRG02660/$$76254798/16D20250219V Lot Number: 6254798

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated