Recall Z-1856-2025 ยท NDP Accessories, Implant, Dental, Endosseous
Prismatik Dentalcraft, Inc.
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 i
| Date | May 28, 2025 (initiated Apr 14, 2025) |
| Status | Open, Classified |
| Reason | Due to packaging mix up. Package of finished devices were reported to have an incorrect finished device package inside. |
| Root cause | Process control |
| Action | On 04/14/2025, the firm sent via overnight mail an "URGENT: VOLUNTARY MEDICAL DEVICE RECALL" Letter to customers informing them that Prismatik had shipped the device, Glidewell HT" Implant Twist Drill 1.5 x 8 mm (Device SKU #: 70-1071-SRG0266) mispackaged with an incorrect finished device, Glidewell HT" Implant Shaping Drill 5.0 x 11.5 mm (Device SKU #: 70-1071-SRG0285) packaged inside. The affected Lot Number is 6254798. Customers are instructed to: 1. Review their inventory for the product received between 03/06/2025 through 03/18/2025 with Lot Number 6254798. If they have any product remai |
| Quantity | 15 units |
| Distribution | U.S Nationwide distribution in the states of KY, MA, MI, NC, VA, and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.