FDAClass IIJune 4, 2025

Glidewell HT Implant Twist Drill ¿1.5 x 8 mm " recall

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

Why was Glidewell HT Implant Twist Drill ¿1.5 x 8 mm " recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Glidewell HT Implant Twist Drill ¿1.5 x 8 mm SKU # 70-1071-SRG0266 UDI code: +D7457071SRG02660/$$76254798/16D20250219V Lot Number: 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…
Recalling firm
Prismatik Dentalcraft, Inc.
Quantity
15 units
Distribution
U.S Nationwide distribution in the states of KY, MA, MI, NC, VA, and WV.
Recall date
June 4, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls