Glidewell HT Implant Drill (Prismatik) – Packaging Mixup (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Glidewell HT Implant Twist Drill 1.5 x 8 mm " SKU # 70-1071-SRG0266 UDI code: +D7457071SRG02660/$$76254798/16D20250219V The Glidewell HT" Implant Twist Drill is indicated to prepare the site for placement of endosseous dental implants when tissue contact will last less than 1 hour. The Glidewell HT" Implant Twist Drill is used to remove bone from osteotomy during dental implant placement. The initial Twist Drill is used to deepen the osteotomy and establish the trajectory of subsequent d
Brand
Prismatik Dentalcraft, Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Glidewell HT Implant Twist Drill ¿1.5 x 8 mm SKU # 70-1071-SRG0266 UDI code: +D7457071SRG02660/$$76254798/16D20250219V Lot Number: 6254798
Prismatik Dentalcraft, Inc. is recalling Glidewell HT Implant Twist Drill 1.5 x 8 mm " SKU # 70-1071-SRG0266 UDI code: +D7457071SRG02660/$$7 due to Due to packaging mix up. Package of finished devices were reported to have an incorrect finished device package inside.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to packaging mix up. Package of finished devices were reported to have an incorrect finished device package inside.
Recommended Action
Per FDA guidance
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 remaining in inventory, collect and quarantine immediately. 2. For the products listed for this recall. discontinue use and if they have any inventory in storage, return the product to receive a credit, using the return form attached with the specific contact information to: RA.Mailbox@glidewelldental.com. 3. If completing the form: indicate the quantities that need to be returned. Sign, date, and return the form to RA.Mailbox@glidewelldental.com. Keep the quarantine product segregated; Prismatik Dentalcraft Customer Service Representative will contacting customers with further instructions. 4. Make a copy of the signed form and place it with the returning product. This will identify the product as Recall Product for proper handling and disposition. 5. If customers do not have product to be returned, place an X next to the statement, No Product to Return , sign, date and return the form to RA.Mailbox@glidewelldental.com. For questions/assistances, contact Regulatory Affairs at RA.Mailbox@glidewelldental.com or (949) 836-5479.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026