FDA Enforcement
Class II
Ongoing
CONTRA GRAY (soft) TURBO PLUS CUPS, REF 153112. Dental Prophylaxis Angles
Recall: Z-0285-2024
·
Reported November 15, 2023
Enforcement
- Recall Number
- Z-0285-2024
- Event ID
- 93176
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Young Dental Manufacturing I, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 15, 2023
- Initiation Date
- October 6, 2023
- Classification Date
- November 9, 2023
- Address
- 13705 Shoreline Ct E, Earth City, MO, 63045-1202, United States
Description
CONTRA GRAY (soft) TURBO PLUS CUPS, REF 153112. Dental Prophylaxis Angles
Reason
one lot of Contra Gray (soft) Turbo Plus Cups Dental Prophylaxis Angles may contain Contra Petite Web LF Soft Purple Cup DPAs.
Code Info
UDI/DI 10302731631127, Lot Number 223466
Distribution
US: IN, TN, MO
Quantity
12 units