Device 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.
Z-2178-2024
Product summary
- Event
- Event 94783
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 192 units
- Official record key
device-enforcement:Z-2178-2024
Official wording
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 information: UDI-DI : D7022645630 (1) P/N 264563: lot # 4874201, lot # 4904771 (2) P/N 264565, lot # 4964531
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
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