FDA Medical Device Recalls (openFDA)
Dental EZ Stardental Division: Titan 3 5K Low-Speed Motor - Star Titan 3, 5,000 rpm- Lube Free
- Recall number
- Z-2354-2010
- Recalling firm
- Dental EZ Stardental Division
- Product
- Titan 3 5K Low-Speed Motor - Star Titan 3, 5,000 rpm- Lube Free
- Status
- Terminated
- Initiated
- 2010-08-11
- Posted
- 2010-09-02
- Terminated
- 2010-12-13
- Reason
- The housing of 5K motor is labeled as a 20K motor.
- Root cause
- Labeling mix-ups
- Action
- DentalEZ group/Star Dental Division sent a "Medical Device Recall" letter to consignees on 8/11/10, informing them that the device's 5K motor was mislabeled as a 20K motor. Customers are to stop using of the device, and return to the manufacturer or to the distributor using supplied shipping labels. Replacement devices will be sent to customers at no charge. Consignees are to complete and return a form indicating whether they have any affected devices, and whether customers have been contacted about this recall. Customers can contact DentalEZ at 866-383-4636 .
- Quantity
- 41 units
- Distribution
- Nationwide Distribution: States of IN and TX
- Lot, serial or model codes
- Part number 262261, Lot number 1925391
- 510(k) numbers
- ["K960260"]
- PMA numbers
- not on file
- Product code
- EFA
- Firm FEI
- 2520265
- Firm city
- Lancaster
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28