CLASS II ONGOING Device recall · Reported 4 Jun 2025 · FDA Enforcement Report
Glidewell HT Implant Twist Drill ¿ " recalled by Prismatik Dentalcraft
Prismatik Dentalcraft is recalling Glidewell HT Implant Twist Drill ¿ ", distributed nationwide in the US. The recall was initiated on 14 Apr 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1856-2025
- FDA event ID
- 96711
- Recalling firm
- Prismatik Dentalcraft, Irvine, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 14 Apr 2025
- FDA classified
- 28 May 2025
- Reported
- 4 Jun 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Dental Devices
Timeline
| 14 Apr 2025 | Recall initiated by company | |
| 28 May 2025 | Classified by FDA | +44 days |
| 4 Jun 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to packaging mix up. Package of finished devices were reported to have an incorrect finished device package inside.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Glidewell HT Implant Twist Drill ¿1.5 x 8 mm " SKU # 70-1071-SRG0266 UDI code: +D7457071SRG02660/$$76254798/16D20250219V The Glidewell HT" Implant Twist Drill is indicated to prepare the site for placement of endosseous dental implants when tissue contact will last less than 1 hour. The Glidewell HT" Implant Twist Drill is used to remove bone from osteotomy during dental implant placement. The initial Twist Drill is used to deepen the osteotomy and establish the trajectory of subsequent drills in the placement of a dental implant. The large Twist Drill is stepped to accmmodate the tapered design of the implant and is available in lengths corresponding to the availble implant lengths. Drill length is calculated to indicate where the top of the implant will reside when fully seated to that depth. The Twist Drill is machined from stainless steel.
Where it was distributed
U.S Nationwide distribution in the states of KY, MA, MI, NC, VA, and WV.
Nationwide KentuckyMassachusettsMichiganNorth CarolinaVirginiaWest Virginia
Questions about this recall
Why was it recalled?
Due to packaging mix up. Package of finished devices were reported to have an incorrect finished device package inside.
Which lots are affected?
Glidewell HT Implant Twist Drill ¿1.5 x 8 mm SKU # 70-1071-SRG0266 UDI code: +D7457071SRG02660/$$76254798/16D20250219V Lot Number: 6254798
Where was it sold?
U.S Nationwide distribution in the states of KY, MA, MI, NC, VA, and WV.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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