Recall Z-2178-2024— Dental EZ Group Star Dental Division

Name: FDA recall Z-2178-2024
Creator: U.S. Food and Drug Administration
Published: 2024-05-30

Class II · Ongoing

Class II FDA medical device recall by Dental EZ Group Star Dental Division, initiated 2024-05-30. It names one FDA 510(k) clearance: K881253. 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: 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.

Recalling firm: Dental EZ Group Star Dental Division
Classification: Class II
Status: Ongoing
Initiated: 2024-05-30
Firm location: Lancaster, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K881253 — ROTORY SCALER SWIVEL IMPROVEMENT FEATURE, TITAN SWDentalez Group·cleared 1988-04-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product 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 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

Data sourced from openFDA. This site is unofficial and independent of the FDA.