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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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.
- Affected units
- 15
Distribution
Related recalls
Same manufacturer · Prismatik Dentalcraft, Inc.
See all →- ModerateSilent Nite Sleep Appliance Recalled Due to Lack of FDA Clearance
FDA (Devices) · 2026-07-29
- HighDental implant screws recalled because the wrong screw was packaged
FDA (Devices) · 2025-11-12
- ModeratePrismatik Recalls BruxZir Shaded Dental Restorations Due to Quarantine Failure
FDA (Devices) · 2016-10-05
Similar recalls
- HighDental implant screws recalled because the wrong screw was packaged
FDA (Devices) · 2025-11-12
- ModerateStraumann Twist Drill PRO Recalled for Tolerance Specification Defects
FDA (Devices) · 2017-01-18
- ModerateZimmer Dental Recalls Spline Twist Implants Due to Labeling Error
FDA (Devices) · 2014-11-05
- ModerateStraumann Dental Implant Drill Set Recalled for Incorrect Drill
FDA (Devices) · 2015-01-21
- ModerateBiomet 3i Recalls Dental Implants Due to Unsealed Pouches
FDA (Devices) · 2016-08-24
- ModerateBiomet 3i Recalls Twist Lock Dental Implants Due to Unsealed Pouches
FDA (Devices) · 2016-08-24