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Lower risk Medical device recall · FDA · Published April 14, 2025

Glidewell HT Implant Twist Drill Recall: Packaging Mix-Up Risk

Prismatik Dentalcraft recalls Glidewell HT Implant Twist Drills due to incorrect packaging. Affected units have a specific SKU and UDI code. No action needed as the hazard is a packaging error.

🇺🇸 FDA recall #Z-1856-2025Medical deviceGlidewell ›
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Contact the company

Recalling firmPrismatik Dentalcraft, Inc.2144 Michelson Dr · Irvine, CA 92612-1304
✎ GovInfoNow plain-language explainer

Prismatik Dentalcraft is recalling Glidewell HT Implant Twist Drills because some packages contained the wrong finished device. This packaging mix-up does not pose a safety risk to users, so no action is required. Read more at govinfonow.com/recall/52454-glidewell-ht-implant-twist-drill-recall-packaging-mix-up-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/52454-glidewell-ht-implant-twist-drill-recall-packaging-mix-up-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1856-2025

Cite this page

“Glidewell HT Implant Twist Drill Recall: Packaging Mix-Up Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52454-glidewell-ht-implant-twist-drill-recall-packaging-mix-up-risk. Based on FDA recall #Z-1856-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1856-2025%22&limit=1).

The FDA announced on April 14, 2025, that Prismatik Dentalcraft, Inc. is recalling Glidewell HT Implant Twist Drill units due to a packaging mix-up hazard. The recall affects 15 units distributed nationwide in Kentucky, Massachusetts, Michigan, North Carolina, Virginia, and West Virginia.

How to tell if you have it

  • Brand: Glidewell
  • Product: Glidewell HT Implant Twist Drill 1.5 x 8 mm
  • SKU: 70-1071-SRG0266
  • UDI code: +D7457071SRG02660/$$76254798/16D20250219V
  • Lot Number: 6254798

The hazard

According to the FDA, packages of finished devices were reported to contain an incorrect finished device package inside due to a packaging mix-up.

Context

GovInfoNow's records show Prismatik Dentalcraft, Inc. has two other recalls on record since September 30, 2025, including the Silent Nite Sleep Appliance Recall from April 27, 2026, and the Inclusive Titanium Screw Recall from September 30, 2025. Other recent recalls of similar products include the Straumann GM Helix Dental Implant Recall (July 13, 2026), the Encore Medical EMPOWR 3D KNEE Ins 11L 14MM VE recall (February 16, 2026), and the Encore Medical EMPOWR 3D Knee Tibial Insert 5R 14MM Recall (January 5, 2026).

How to tell if you have this one

Check for the SKU #70-1071-SRG0266 and UDI code +D7457071SRG02660 on the product label. The product was sold with a specific lot number (6254798).

  • Brand
    Glidewell
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Label

    Look for the SKU #70-1071-SRG0266 and UDI code +D7457071SRG02660 on the product label.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 6 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: named in the noticeMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: nationwideCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: named in the noticeNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: nationwideTXFlorida: nationwideFL

FDA distribution: “U.S Nationwide distribution in the states of KY, MA, MI, NC, VA, and WV.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Kentucky, Massachusetts, Michigan, North Carolina, Virginia, West Virginia.

Recall timeline

FDA published this recall 51 days after the firm started it.

1. Firm started the recall: Apr 14, 202512. FDA classified it Class II: May 28, 202523. Published in FDA’s Enforcement Report: Jun 4, 202532025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

What should I do if I have this product?

No action is required. The product is safe to use as intended.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1856-2025 (April 14, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1856-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA