The Recall Desk
ModerateFDA (Devices)·Z-2178-2024·Announced 2024-07-03

Sonic Scaler Tip Holder May Be Oversized, Preventing Proper Seating

The tip holder portion of Titan Blis-Sonic Scaler tips may be oversized, preventing proper seating in the scaler handpiece. This defect could result in the tip becoming loose during use.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This FDA Class II recall describes a mechanical defect with potential to cause injury, but no injuries or illnesses have been reported. The hazard is theoretical and would be apparent during clinical use, placing it within the Moderate (2) classification.

Plain-English summary

Dental EZ Group Star Dental Division is recalling the Titan Blis-Sonic Scaler packaged with the Titan Scaler Tip - Perio (part number 261669). The affected product was distributed nationwide. Approximately 192 units are involved in this recall.

The defect is in the tip holder portion of the scaler tip assembly. The tip holder may be oversized, which prevents the scaler tip from staying seated properly in the holder. This defect could allow the scaler tip to become loose or disengage during use.

A loose or disengaged scaler tip during clinical use may cause injury to the patient or dental professional. No injuries have been reported to date related to this defect.

Healthcare providers who have used these products should inspect the affected lot numbers (4874201, 4904771, and 4964531) to verify that the scaler tips are functioning properly and remaining fully seated during use.

The recalled product

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 mandibu
Manufacturer
Dental EZ Group Star Dental Division
Hazard
  • mechanical-defect
  • disengagement-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • UDI-DI : D7022645630 (1) P/N 264563: lot # 4874201
  • lot # 4904771 (2) P/N 264565
  • lot # 4964531

Distribution

Distributed nationwide across the United States.