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.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a functional fit issue without reporting any injuries, illnesses, or hospitalizations, aligning with the criteria for moderate severity.
Plain-English summary
Coltene Whaledent Inc is recalling 7,206 units of the HYGENIC Wingless Fiesta Kit, Model no. H02790. The product consists of dental dam forceps intended to be used with rubber dental dams and clamps. The recall is limited to specific batches identified by laser-marked batch numbers 1903, 1904, 1906, 1907, 1909, 1910, 1911, 1915, 1920, 1921, 1923, 1927, 1928, 1930, 1934, and 1940.
The recall was initiated because multiple batches of the forceps have a pin size larger than acceptable. This defect may make it difficult for the forceps to fit appropriately with dental dam clamps. The distribution pattern is currently listed as pending.
Distributors and end users who received the affected batches should check the laser-marked batch numbers on the forceps. If the forceps have one of the listed batch numbers and do not fit with the dental dam clamps, they should be returned to Coltene.
The recalled product
- 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.
- Manufacturer
- Coltene Whaledent Inc
- Hazard
- Affected units
- 7,206
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 recalled by Coltene Whaledent Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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