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Recall Observatory FDA recall evidence

Device 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.

Z-2420-2020

June 03, 2020

Class II

Product summary

Firm
Coltene Whaledent Inc
Event
Event 85794
Status
Ongoing
Classification
Class II
Quantity
7,206 forceps
Official record key
device-enforcement:Z-2420-2020

Official wording

Reason: 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.

Code information: Batch numbers: J73571 If a distributor or end user received one of the batches listed above, they need to look at the batch number laser marked on the forceps themselves. If the forceps has any of the following batch numbers laser marked on them and the forceps do not fit with the dental dam clamps, the forceps should be returned to Coltene. Laser marked batch number: 1903 1904 1906 1907 1909 1910 1911 1915 1920 1921 1923 1927 1928 1930 1934 1940

Distribution pattern: Pending

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.