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.
Reported: July 1, 2020 Initiated: June 3, 2020 #Z-2421-2020
Product Description
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.
Reason for Recall
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.
Details
- Recalling Firm
- Coltene Whaledent Inc
- Units Affected
- 7,206 forceps
- Distribution
- Pending
- Location
- Cuyahoga Falls, OH
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Coltene Whaledent Inc. Units affected: 7,206 forceps.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 1, 2020. Severity: Moderate. Recall number: Z-2421-2020.
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