The Recall Desk

FDA (Devices) recall action 94783

Dental EZ Group Star Dental Division recalled 2 products on 2024-07-03

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2024-07-03
Critical
0
Units
224

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • HighFDA (Devices)··2024-07-03

    Dental Scaler Tip May Not Seat Properly, Posing Injury Risk

    Dental EZ Group is recalling certain Titan Scaler Tip (Perio, Model 261669) units due to an oversized tip holder condition that may prevent proper seating, creating a risk of injury during use.

    Product
    Titan Scaler Tip - Perio Model/Catalog Number: 261669 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.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··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.

    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
    Category
    Distribution
    0 states