Class 2 Device Recall Glidewell HT

• Date Initiated by Firm: April 14, 2025
• Date Posted: May 28, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1856-2025
• Recall Event ID: 96711
• Product Classification: Accessories, implant, dental, endosseous - Product Code NDP
• Product: Glidewell HT Implant Twist Drill 1.5 x 8 mm " SKU # 70-1071-SRG0266 UDI code: +D7457071SRG02660/$$76254798/16D20250219V The Glidewell HT" Implant Twist Drill is indicated to prepare the site for placement of endosseous dental implants when tissue contact will last less than 1 hour. The Glidewell HT" Implant Twist Drill is used to remove bone from osteotomy during dental implant placement. The initial Twist Drill is used to deepen the osteotomy and establish the trajectory of subsequent drills in the placement of a dental implant. The large Twist Drill is stepped to accmmodate the tapered design of the implant and is available in lengths corresponding to the availble implant lengths. Drill length is calculated to indicate where the top of the implant will reside when fully seated to that depth. The Twist Drill is machined from stainless steel.
• Code Information: Glidewell HT Implant Twist Drill ¿1.5 x 8 mm SKU # 70-1071-SRG0266 UDI code: +D7457071SRG02660/$$76254798/16D20250219V Lot Number: 6254798
• FEI Number: 3011649314
• Recalling Firm/ Manufacturer: Prismatik Dentalcraft, Inc.; 2144 Michelson Dr; Irvine CA 92612-1304
• For Additional Information Contact: Michelle (Shelly) Gallup; 949-222-3590
• Manufacturer Reason for Recall: Due to packaging mix up. Package of finished devices were reported to have an incorrect finished device package inside.
• FDA Determined 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 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.
• Quantity in Commerce: 15 units
• Distribution: U.S Nationwide distribution in the states of KY, MA, MI, NC, VA, and WV.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.