The Recall Desk

FDA (Devices) recall action 85794

Coltene Whaledent Inc recalled 4 products on 2020-07-01

The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2020-07-01
Critical
0
Units
28,824

Why these products were recalled

Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it difficult for the forceps to fit appropriately with dental dam clamps.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–4 of 4

  • ModerateFDA (Devices)··2020-07-01

    Coltene Recalls Dental Dam Forceps Due to Pin Size Defect

    Coltene Whaledent Inc is recalling 7,206 HYGENIC Wingless Fiesta Kit forceps because a pin size defect may prevent them from fitting dental dam clamps.

    Product
    HYGENIC Wingless Fiesta Kit, Model no. H02790 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2020-07-01

    Coltene Recalls HYGENIC Dental Dam Forceps Due to Pin Size Defect

    Coltene Whaledent Inc is recalling 7,206 HYGENIC Dental Dam Forceps because a pin size defect may prevent them from fitting properly with dental dam clamps.

    Product
    HYGENIC Dental Dam Forceps, Model no. H01262 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2020-07-01

    Coltene Recalls HYGENIC Simple Dam Kit Forceps Due to Fit Issues

    Coltene Whaledent Inc is recalling 7,206 HYGENIC Simple Dam Kit forceps because a pin size defect may prevent them from fitting properly with dental dam clamps.

    Product
    HYGENIC Simple Dam Kit, Model no. 60019066 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2020-07-01

    Coltene Recalls Dental Dam Forceps Due to Pin Size Defect

    Coltene Whaledent Inc is recalling 7,206 dental dam forceps because a pin size defect may prevent them from fitting properly with dental dam clamps.

    Product
    HYGENIC Winged Fiesta Kit, Model no. H02778 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam.
    Category
    Distribution
    0 states