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

Glidewell HT Implant Twist Drill recalled due to packaging mix-up

Prismatik Dentalcraft is recalling Glidewell HT Implant Twist Drill 1.5 x 8 mm devices due to a packaging mix-up that resulted in incorrect finished devices being placed in packages.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall. The hazard is a packaging/labeling issue (incorrect device in package) with no reported illnesses or injuries, which falls under minor labeling/packaging errors per the rubric.

Plain-English summary

Prismatik Dentalcraft, Inc. is recalling the Glidewell HT Implant Twist Drill 1.5 x 8 mm (SKU # 70-1071-SRG0266, UDI code +D7457071SRG02660/$$76254798/16D20250219V, Lot Number 6254798) due to a packaging mix-up. Packages of finished devices were reported to have an incorrect finished device inside.

The Glidewell HT Implant Twist Drill is a stainless steel device intended to prepare sites for endosseous dental implant placement. A total of 15 units were affected. The product was distributed nationwide in Kentucky, Massachusetts, Michigan, North Carolina, Virginia, and West Virginia.

Customers who have received this product should contact Prismatik Dentalcraft, Inc. to report any concerns or to arrange a replacement.

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.
Category
Medical Device — Dental Implant Surgical Instrument
Hazard
  • packaging-mix-up
  • wrong-device-in-package

Distribution

Distributed nationwide across the United States.

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