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RecallWatchMedical Device Safety
Class IIOngoingZ-1856-2025

Prismatik Dentalcraft, Inc. recalls Glidewell HT Implant Twist Drill ¿1.5 x 8 mm " SKU # 70-1071-SRG0266 UDI code: +D74570…

Prismatik Dentalcraft, Inc.Irvine, CA, United StatesReported Jun 4, 2025 · 1 year ago
Legal News Analyst ·

Reason for recall

Due to packaging mix up. Package of finished devices were reported to have an incorrect finished device package inside.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • 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
    UDI code
    Affected lot
    6254798

What the firm is doing

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: RA.Mailbox@glidewelldental.com. 3. If completing the form: indicate the quantities that need to be returned. Sign, date, and return the form to RA.Mailbox@glidewelldental.com. 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 RA.Mailbox@glidewelldental.com. For questions/assistances, contact Regulatory Affairs at RA.Mailbox@glidewelldental.com or (949) 836-5479.

DistributionShow details

U.S Nationwide distribution in the states of KY, MA, MI, NC, VA, and WV.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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