Glidewell HT Implant Twist Drill ¿1.5 x 8 mm " SKU # 70-1071-SRG0266 UDI code: +D7457071SRG02660/$$76254798/16D20250219V The Glidewel...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1856-2025.
Due to packaging mix up. Package of finished devices were reported to have an incorrect finished device package inside.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1856-2025.
Recall ongoing. Follow firm instructions.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact Prismatik Dentalcraft, Inc. or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- If you've been hurt by this product, report the incident to FDA.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1856-2025.
Prismatik Dentalcraft, Inc.
About the U.S. Food and Drug Administration
The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.
Visit FDA.gov →📣 Report a food, supplement, or cosmetic problem to the FDA
If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.
Prismatik Dentalcraft, Inc. Recall FAQ
Prismatik Dentalcraft, Inc. is the subject of a medical implants safety report: Glidewell HT Implant Twist Drill ¿1.5 x 8 mm " SKU # 70-1071-SRG0266 UDI code: +D7457071SRG02660/$$76254798/16D20250219V The Glidewel.... The notice was published on April 14, 2025 by the U.S. Food and Drug Administration (FDA). Approximately 15 units are potentially affected.