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.
- Company
- Coltene Whaledent Inc
- Recall Initiated
- June 3, 2020
- Recall Number
- Z-2421-2020
- Quantity
- 7,206 forceps
- Firm Location
- Cuyahoga Falls, OH
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.
Distribution
Pending
Lot / Code Info
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
Root Cause
Process control
Action Taken
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