Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0285-2024Class II

CONTRA GRAY (soft) TURBO PLUS CUPS, REF 153112. Dental Prophylaxis Angles

Young Dental Manufacturing Co 1, LLC. / initiated 2023-10-06 / Open, Classified / root cause: packaging

Young Dental Manufacturing I, LLC began a recall of CONTRA GRAY (soft) TURBO PLUS CUPS, REF 153112. Dental Prophylaxis Angles on . FDA classified it as Class II and gives the reason as "one lot of Contra Gray (soft) Turbo Plus Cups Dental Prophylaxis Angles may contain Contra Petite Web LF Soft Purple Cup DPAs". As of , the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number
Z-0285-2024
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Young Dental Manufacturing Co 1, LLC.
Product
CONTRA GRAY (soft) TURBO PLUS CUPS, REF 153112. Dental Prophylaxis Angles
Product code
EGS Handpiece, Contra- And Right-Angle Attachment, Dental
Reason for recall
one lot of Contra Gray (soft) Turbo Plus Cups Dental Prophylaxis Angles may contain Contra Petite Web LF Soft Purple Cup DPAs.
Root cause tag
packaging
FDA root cause
Packaging process control
Action
Young Dental Manufacturing CO 1, LLC issued a MEDICAL DEVICE RECALL notice to its consignees on 10/06/2023 by USPS certified mail with return receipt notification. The notice explained the issue and requested that the product be returned or destroyed. Distributors were directed to notify their customers. Replacement product will be provided directly from the recalling firm; refunds will be handled through the distributor and credit issued.
Quantity in commerce
12 units
Distribution
US: IN, TN, MO
Product codes and lots
UDI/DI 10302731631127, Lot Number 223466

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0285-2024
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0285-2024Class IIOngoingVoluntary: Firm initiated