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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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. The hazard is a functional fit issue that may make it difficult to use the device, but no injuries or illnesses are reported, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Coltene Whaledent Inc is recalling 7,206 units of the HYGENIC Simple Dam Kit, Model no. 60019066. The recall involves dental dam forceps intended to be used with rubber dental dams and clamps. The specific 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 affected forceps are identified by specific laser-marked batch numbers: 1903, 1904, 1906, 1907, 1909, 1910, 1911, 1915, 1920, 1921, 1923, 1927, 1928, 1930, 1934, and 1940. The distribution pattern is currently listed as pending.
Distributors and end users who received these batches should check the laser-marked batch number 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 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.
- 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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