FDAJune 3, 2020device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
coltene whaledentcoltene
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDASciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations and for polishing teeth. Model Number: S100012023-01-20
- FDADental pins - TMS LINK PLUS Self-Threading Pins - Product Usage: implanted into the teeth or for lab use for dental restoration purposes. The normal procedure requires a hole to be drilled into the tissue of a tooth with an intraoral drill prior to installation. Model number/Catalog number: L7412021-03-18
- FDAStrauss 25 Carbide Dental Burs (100057XXV)2020-10-20
- FDAClinic Pack 100 Pieces FG 57 100057C (100057C)2020-10-20
- FDACEI Cutting Edge Instruments (PTC-57C)2020-10-20
- FDAAlpen Clinic 100 Carbide Instruments (R100057C)2020-10-20
- FDAFG 57 100057X (100057X)2020-10-20
- FDAHYGENIC 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.2020-06-03
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