Glidewell HT Implant Twist Drill ¿1 — Class II medical device recall Z-1856-2025
Ongoing recall by Prismatik Dentalcraft, Inc., reported 2025-06-04, distributed nationwide. Due to packaging mix up. Package of finished devices were reported to have an incorrect finished device packag
| Recall number | Z-1856-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Prismatik Dentalcraft, Inc., Irvine, CA, United States |
| Recall initiated | 2025-04-14 |
| Classified | 2025-05-28 |
| Reported by FDA | 2025-06-04 |
| Distributed | Nationwide (US) |
| Quantity | 15 units |
| Lot numbers | 6254798 |
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 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.
Reason for recall
Due to packaging mix up. Package of finished devices were reported to have an incorrect finished device package inside.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.