FDA recall Z-2178-2024

Dental EZ Group Star Dental Division · Class II · 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.

Reason for recall

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

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2024-05-30
Report date
2024-07-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lancaster, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2178-2024