Z-1856-2025Class II

Glidewell HT Implant Twist Drill 1.5 x 8 mm " SKU # 70-1071-SRG0266 UDI code...

Name: Z-1856-2025 Glidewell HT Implant Twist Drill 1.5 x 8 mm " SKU # 70-1071-SRG0266 UDI code...
Creator: Prismatik Dentalcraft, Inc.
Published: 2025-04-14
License: https://open.fda.gov/license/

Prismatik Dentalcraft, Inc. / initiated 2025-04-14 / Open, Classified / root cause: manufacturing process

FDA source

Prismatik Dentalcraft, Inc. began a recall of 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... on 2025-04-14. FDA classified it as Class II and gives the reason as "Due to packaging mix up. Package of finished devices were reported to have an incorrect finished device package inside". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1856-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-04-14
Posted: 2025-05-28
Recalling firm: Prismatik Dentalcraft, Inc.
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.
Product code: NDP Accessories, Implant, Dental, Endosseous
Reason for recall: Due to packaging mix up. Package of finished devices were reported to have an incorrect finished device package inside.
Root cause tag: manufacturing process
FDA root 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: [email protected]. 3. If completing the form: indicate the quantities that need to be returned. Sign, date, and return the form to [email protected]. 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 [email protected]. For questions/assistances, contact Regulatory Affairs at [email protected] 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.
Product codes and lots: Glidewell HT Implant Twist Drill ¿1.5 x 8 mm SKU # 70-1071-SRG0266 UDI code: +D7457071SRG02660/$$76254798/16D20250219V Lot Number: 6254798

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1856-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1856-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-04	2025-05-28

Product code NDP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)