FDAFDA · Food and drugs·Recall number Z-2178-2024
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.
Published July 3, 2024 · Recall initiated: May 30, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Dental EZ Group Star Dental Division
- Distributor
- US Nationwide distribution.
- Lot
- UDI-DI : D7022645630 (1) P/N 264563: lot # 4874201, lot # 4904771 (2) P/N 264565, lot # 4964531
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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