Z-2354-2010

Titan 3 5K Low-Speed Motor - Star Titan 3, 5,000 rpm- Lube Free

Name: Z-2354-2010 Titan 3 5K Low-Speed Motor - Star Titan 3, 5,000 rpm- Lube Free
Creator: Dental EZ Stardental Division
Published: 2010-08-11
License: https://open.fda.gov/license/

Dentalez, Inc., Stardental Division / initiated 2010-08-11 / Terminated / root cause: labeling and UDI

FDA source

Dental EZ Stardental Division began a recall of Titan 3 5K Low-Speed Motor - Star Titan 3, 5,000 rpm- Lube Free on 2010-08-11. The reason FDA records is "The housing of 5K motor is labeled as a 20K motor". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2354-2010
Status: Terminated
Initiated: 2010-08-11
Posted: 2010-09-02
Terminated: 2010-12-13
Recalling firm: Dentalez, Inc., Stardental Division
Product: Titan 3 5K Low-Speed Motor - Star Titan 3, 5,000 rpm- Lube Free
Product code: EFA Handpiece, Belt And/Or Gear Driven, Dental
Reason for recall: The housing of 5K motor is labeled as a 20K motor.
Root cause tag: labeling and UDI
FDA 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 in commerce: 41 units
Distribution: Nationwide Distribution: States of IN and TX
Product codes and lots: Part number 262261, Lot number 1925391

Product code EFA

K960260Class IStar Titan Series Motors & AttachmentsDentalez Group / cleared 1996-03-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)