Z-2178-2024Class II

Titan Blis-Sonic Scaler packaged with the Titan Scaler Tip - Perio (part number 261669) (1) P/N 264563 (2)...

Name: Z-2178-2024 Titan Blis-Sonic Scaler packaged with the Titan Scaler Tip - Perio (part number 261669) (1) P/N 264563 (2)...
Creator: Dental EZ Group Star Dental Division
Published: 2024-05-30
License: https://open.fda.gov/license/

Dentalez, Inc., Stardental Division / initiated 2024-05-30 / Open, Classified / root cause: manufacturing process

FDA source

Dental EZ Group Star Dental Division began a recall of Titan Blis-Sonic Scaler packaged with the Titan Scaler Tip - Perio (part number 261669) (1) P/N 264563 (2) P/N 264565 The scaler tip is used with an air drive... on 2024-05-30. FDA classified it as Class II and gives the reason as "Tip holder portion of the scaler tip assembly may have an oversized condition that will not allow the scaler tip to stay seated in the holder may cause injury". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2178-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-05-30
Posted: 2024-06-24
Recalling firm: Dentalez, Inc., Stardental Division
Product: Titan Blis-Sonic Scaler packaged with the Titan Scaler Tip - Perio (part number 261669) (1) P/N 264563 (2) P/N 264565 The scaler tip is used with an air drive scaler for subgingival scaling and fine access. The Perio tip is used for lingual supragingival scaling of mandibular incisors and deep local pockets.
Product code: ELC Scaler, Ultrasonic
Reason for recall: Tip holder portion of the scaler tip assembly may have an oversized condition that will not allow the scaler tip to stay seated in the holder may cause injury
Root cause tag: manufacturing process
FDA root cause: Process control
Action: DentalEZ Inc., StarDental Division issued Medical Device Recall Letter on 5/30/24 via Certified Mail to End-Users and Distributors. Letter states reason for recall, health risk and action to take: DentalEZ Inc., StarDental Divison requests that you immediately cease use/ distribution of the above referenced lot and return any that you have under your control to DentalEZ Inc, StarDental Division, 1816 Colonial Village Lane, Lancaster, PA 17601-5864 using the enclosed UPS RS label. Upon receipt, we will replace the Perio tip in the package and return it to you at no cost. We also request that you contact your customers that have purchased any of the above referenced Blissonic Scalers from the referenced lot. Please direct your customers to go to our website at DentalEZ.com and follow the instructions below in order to have the Perio scaler tip shipped directly to StarDental at no charge. Upon receipt of the Perio tip, we will replace the tip directly to your customer at no charge. Please complete and return the enclosed form by July 1, 2024, indicating whether you have any of the effected lot of Blis-sonic Scalers and whether you are able to contact your customers regarding this recall notification as well. Any questions and concerns should be forwarded to Kay Engle at [email protected].
Quantity in commerce: 192 units
Distribution: US Nationwide distribution.
Product codes and lots: UDI-DI : D7022645630 (1) P/N 264563: lot # 4874201, lot # 4904771 (2) P/N 264565, lot # 4964531

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2178-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2177-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-03	2024-06-24
Z-2178-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-03	2024-06-24

Product code ELC

K881253Class IIRotory Scaler Swivel Improvement Feature, Titan SwDentalez Group / cleared 1988-04-21

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)