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.
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 hazard is a functional fit issue (pin size) rather than a direct safety risk like injury or contamination, aligning with the 'Moderate' criteria for minor defects or low-risk issues.
Plain-English summary
Coltene Whaledent Inc is recalling 7,206 units of the HYGENIC Winged Fiesta Kit, Model no. H02778. The recall involves dental dam forceps intended to be used with rubber dental dams and clamps. The defect is that multiple batches have a pin size larger than acceptable, which may make it difficult for the forceps to fit appropriately with the dental dam clamps.
The recall covers specific batch numbers: J38382, J28715, J24868, J28716, J33647, J43944, J50980, J47108, J57802, J57061, J67133, J74174, J68563, and J72691. Distributors and end users should check the batch number laser-marked on the forceps. If the forceps have one of the listed laser-marked batch numbers (1903, 1904, 1906, 1907, 1909, 1910, 1911, 1915, 1920, 1921, 1923, 1927, 1928, 1930, 1934, or 1940) and do not fit with the dental dam clamps, they should be returned to Coltene.
The recalled product
- 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.
- 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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