FDA Enforcement
Class II
Ongoing
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.
Recall: Z-2178-2024
·
Reported July 3, 2024
Enforcement
- Recall Number
- Z-2178-2024
- Event ID
- 94783
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Dental EZ Group Star Dental Division
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 3, 2024
- Initiation Date
- May 30, 2024
- Classification Date
- June 24, 2024
- Address
- 1816 Colonial Village Ln, Lancaster, PA, 17601-5807, United States
Description
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.
Reason
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
Code Info
UDI-DI : D7022645630 (1) P/N 264563: lot # 4874201, lot # 4904771 (2) P/N 264565, lot # 4964531
Distribution
US Nationwide distribution.
Quantity
192 units