Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
Glidewell HT Implant Twist Drill ¿1.5 x 8 mm " SKU # 70-1071-SRG0266 UDI code: +D7457071SRG02660/$$76254798/16D20250219V The Glidewell HT" Implant Twist Drill is indicated to prepare the site for placement of endosseous dental implants when tissue contact will last less than 1 hour. The Glidewell HT" Implant Twist Drill is used to remove bone from osteotomy during dental implant placement. The initial Twist Drill is used to deepen the osteotomy and establish the trajectory of subsequent drills in the placement of a dental implant. The large Twist Drill is stepped to accmmodate the tapered design of the implant and is available in lengths corresponding to the availble implant lengths. Drill length is calculated to indicate where the top of the implant will reside when fully seated to that depth. The Twist Drill is machined from stainless steel.
Why it was recalled
Due to packaging mix up. Package of finished devices were reported to have an incorrect finished device package inside.
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
Glidewell HT Implant Twist Drill ¿1.5 x 8 mm SKU # 70-1071-SRG0266 UDI code: +D7457071SRG02660/$$76254798/16D20250219V Lot Number: 6254798
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
U.S Nationwide distribution in the states of KY, MA, MI, NC, VA, and WV.
Recall record
- Recalling firm
- Prismatik Dentalcraft, Inc.
- Product type
- Devices
- Recall number
- Z-1856-2025
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Letter
- Origin
- Irvine, CA
- Recall initiated
- 2025-04-14
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-1856-2025 · Source: openFDA enforcement.