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Terminated

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

FDA Recall Z-2354-2010 · Posted 2010-09-02

Recalling FirmDental EZ Stardental Division
Recall StatusTerminated
Product CodeEFA
Date Initiated2010-08-11
Date Terminated2010-12-13
Product Quantity41 units

Reason for Recall

The housing of 5K motor is labeled as a 20K motor.

Firm 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 .

Root Cause

Labeling mix-ups

Distribution Pattern

Nationwide Distribution: States of IN and TX

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K960260STAR TITAN SERIES MOTORS & ATTACHMENTSDentalez Group · 1996-03-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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