Glidewell HT Implant Twist Drill ¿1.5 x 8 mm " SKU # 70-1071-SRG0266 UDI code: +D7457071SRG02660/$$76254798/16D20250219
Summary
The FDA issued a Class II for Glidewell HT Implant Twist Drill ¿1.5 x 8 mm " SKU # 70-1071-SRG0266 UDI code: by Prismatik Dentalcraft, Inc.. Reason: Due to packaging mix up. Package of finished devices were reported to have an incorrect finished device package inside..
Details
Source
Device Recall
External ID
Z-1856-2025
Action Date
2025-06-04
Status
Ongoing
Category
device
Product Description
Glidewell HT Implant Twist Drill ¿1.5 x 8 mm " SKU # 70-1071-SRG0266 UDI code: +D7457071SRG02660/$$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.
Lot/Code Info: Glidewell HT Implant Twist Drill ¿1.5 x 8 mm SKU # 70-1071-SRG0266 UDI code: +D7457071SRG02660/$$76254798/16D20250219V Lot Number: 6254798
Quantity Affected: 15 units
Reason for Recall
Due to packaging mix up. Package of finished devices were reported to have an incorrect finished device package inside.
Distribution
U.S Nationwide distribution in the states of KY, MA, MI, NC, VA, and WV.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-04-14
Company
Irvine, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 185 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Prismatik Dentalcraft, Inc. has 26 FDA actions in our database, including 2 recalls and 24 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Prismatik Dentalcraft, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Prismatik Dentalcraft, Inc. have FDA actions?
Prismatik Dentalcraft, Inc. has 26 FDA actions in our database, including 2 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1856-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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