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U.S. Department of Health and Human Services

Class 2 Device Recall HYGENIC Dental Dam Forceps

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  Class 2 Device Recall HYGENIC Dental Dam Forceps see related information
Date Initiated by Firm June 03, 2020
Create Date June 23, 2020
Recall Status1 Open3, Classified
Recall Number Z-2421-2020
Recall Event ID 85794
Product Classification Forceps, rubber dam clamp - Product Code EJG
Product 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.
Code Information Batch numbers:  J38382   J28715   J24868   J28716   J33647   J43944  J50980   J47108   J57802   J57061   J67133   J74174   J68563  J72691   If a distributor or end user received one of the batches listed above, they need to look at the batch number laser marked on the forceps themselves. If the forceps has any of the following batch numbers laser marked on them and the forceps do not fit with the dental dam clamps, the forceps should be returned to Coltene. Laser marked batch number:  1903 1904 1906 1907 1909 1910 1911 1915 1920 1921 1923 1927 1928 1930 1934 1940
Recalling Firm/
Manufacturer		 Coltene Whaledent Inc
235 Ascot Pkwy
Cuyahoga Falls OH 44223-3701
For Additional Information Contact Nancy Spencer
330-916-8858
Manufacturer 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.
FDA Determined
Cause 2		 Process control
Action The firm notified affected customers on June 3, 2020 by sending out Urgent Medical Device Recall letters. Customers were informed that multiple batches of the product do not meet specification. If you received one of the affected batches, please check the laser marked batch number on the forceps. If the laser marked batch number directly on the forceps matches one of the listed numbers, you should return the forceps. The recalling firm will replace your product at no cost. If you have already used the product, please inform the firm. If you should have additional questions, please contact: Tricia Cregger, Ph.D., RAC, CBA Director of Regulatory / R&D Coltene/Whaledent, Inc. 235 Ascot Parkway Cuyahoga Falls, OH 44223 USA Tricia.Cregger@coltene.com Phone: 330-916-8817 Fax: 330-916-7093
Quantity in Commerce 7,206 forceps
Distribution Pending
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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