Glidewell HT Implant Twist Drill 1.5 x 8 mm " SKU # 70-1071-SRG0266 UDI code: +D7457071SRG02660/$$76254798/16D20250219V

FDA device recall Z-1856-2025 · posted 2025-05-28 · Open, Classified

Recall details

Recalling firm

Prismatik Dentalcraft, Inc.

Reason for recall

Due to packaging mix up. Package of finished devices were reported to have an incorrect finished device package inside.

Action taken

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.

Root cause

Process control

Status

Open, Classified

Product code

NDP

Quantity affected

15 units

Distribution

U.S Nationwide distribution in the states of KY, MA, MI, NC, VA, and WV.

Date initiated

2025-04-14

Date posted

2025-05-28

Location

Irvine, CA