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.
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, but the defect is a functional fit issue with no reported injuries or illnesses, aligning with the 'Moderate' criteria for low-risk or precautionary recalls.
Plain-English summary
Coltene Whaledent Inc is recalling 7,206 units of HYGENIC Dental Dam Forceps, Model no. H01262. The recall is due to a manufacturing defect where the pin size on the forceps is larger than acceptable. This defect may make it difficult for the forceps to fit appropriately with dental dam clamps, which are used to place and remove the clamps from the rubber dental dam.
The affected products are identified by specific batch numbers: J16743, J16745, J29784, J31289, J33607, J44177, J44178, J44840, J47109, J47110, J49167, J67132, J73572, J73785, and J74711. Distributors and end users should check the batch number laser-marked on the forceps. If the forceps has one of the following laser-marked batch numbers (1903, 1904, 1906, 1907, 1909, 1910, 1911, 1915, 1920, 1921, 1923, 1927, 1928, 1930, 1934, or 1940) and does not fit with the dental dam clamps, it should be returned to Coltene.
The distribution pattern for this recall is currently pending. No illnesses or injuries have been reported in connection with this defect.
The recalled product
- 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.
- 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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