Recall Z-2420-2020— Coltene Whaledent Inc
Class II · Ongoing
Class II FDA medical device recall by Coltene Whaledent Inc, initiated 2020-06-03. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..
- Recalling firm
- Coltene Whaledent Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2020-06-03
- Firm location
- Cuyahoga Falls, OH, United States
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.