Z-2078-2014Class II

Titan T 5K Motor

Name: Z-2078-2014 Titan T 5K Motor
Creator: Dental EZ Group Star Dental Division
Published: 2014-06-13
License: https://open.fda.gov/license/

Dentalez, Inc., Stardental Division / initiated 2014-06-13 / Terminated / root cause: manufacturing process

FDA source

Dental EZ Group Star Dental Division began a recall of Titan T 5K Motor Product Usage: Low-speed motor is used with various attachments to perform a variety of dental procedures including caries removal, finishing... on 2014-06-13. FDA classified it as Class II and gives the reason as "The housing of 5K motor was laser marked incorrectly as a 20K motor. The recall was expanded in September 2014 to include additional lot #2251181". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2078-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-13
Posted: 2014-07-17
Terminated: 2015-02-24
Recalling firm: Dentalez, Inc., Stardental Division
Product: Titan T 5K Motor Product Usage: Low-speed motor is used with various attachments to perform a variety of dental procedures including caries removal, finishing, polishing, pin setting and prophy.The motor has a speed range of 100 to 5000 rpm capability.
Product code: EFA Handpiece, Belt And/Or Gear Driven, Dental
Reason for recall: The housing of 5K motor was laser marked incorrectly as a 20K motor. The recall was expanded in September 2014 to include additional lot #2251181.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Star Dental sent a Medical Device Recall letter, dated June 13, 2014 to affected customers. This letter identified the affected product, problem, and actions to be taken. For question call 866-383-4636 extension 4350. The recall was expanded in September 2014 to include additional lot #2251181. A letter, dated September 2014 was sent to customers who were impacted by the recall expansion.
Quantity in commerce: 45
Distribution: US Distribution in the states of : IN, TN, WA, CA, UT, MN, and NY.
Product codes and lots: Lot # 2239818, Model - Titan-T 5K Motor, Catalog Number - 263940, with serial numbers: AC00001M7, AC00002M7, AC00003M7, AC00004M7, AC00005M7, AC00006M7, AC00007M7, AC00008M7, AC00009M7, AC00010M7, AC00011M7, AC00012M7 , AC00013M7, AC00014M7, AC00015M7, AC00016M7, AC00017M7, AC00018M7, AC00019M7, AC00020M7, AC00021M7, AC00022M7, AC00023M7, AC00024M7, AC00025M7 The recall was expanded in September 2014 to include additional lot #2251181 (catalog #263940) with serial numbers: AC00026M7, AC00027M7, AC00028M7, AC00029M7 , AC00030M7, AC00031M7, AC00032M7, AC00033M7, AC00034M7, AC00035M7 , AC00036M7, AC00037M7, AC00038M7, AC00039M7, AC00040M7, AC00041M7 , AC00042M7, AC00043M7, AC00044M7, AC00045M7.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2078-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2078-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-23	2014-07-17

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)