FDAFDA · Food and drugs·Recall number Z-1856-2025
Glidewell HT Implant Twist Drill ¿1.5 x 8 mm " SKU # 70-1071-SRG0266 UDI code: +D7457071SRG02660/$$76254798/16D20250219V The Glidewell HT" Implant Twist Drill is indicated to prepare the site for placement of endosseous dental implants when tissue contact will last less than 1 hour. The Glidewell HT" Implant Twist Drill is used to remove bone from osteotomy during dental implant placement. The initial Twist Drill is used to deepen the osteotomy and establish the trajectory of subsequent drills in the placement of a dental implant. The large Twist Drill is stepped to accmmodate the tapered design of the implant and is available in lengths corresponding to the availble implant lengths. Drill length is calculated to indicate where the top of the implant will reside when fully seated to that depth. The Twist Drill is machined from stainless steel.
Published June 4, 2025 · Recall initiated: April 14, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Due to packaging mix up. Package of finished devices were reported to have an incorrect finished device package inside.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Prismatik Dentalcraft, Inc.
- Distributor
- U.S Nationwide distribution in the states of KY, MA, MI, NC, VA, and WV.
- Lot
- Glidewell HT Implant Twist Drill ¿1.5 x 8 mm SKU # 70-1071-SRG0266 UDI code: +D7457071SRG02660/$$76254798/16D20250219V Lot Number: 6254798
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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