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Open, Classified

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.

FDA Recall Z-2421-2020 · Posted None

Recalling FirmColtene Whaledent Inc
Recall StatusOpen, Classified
Product CodeEJG
Date Initiated2020-06-03
Product Quantity7,206 forceps

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.

Firm 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 [email protected] Phone: 330-916-8817 Fax: 330-916-7093

Root Cause

Process control

Distribution Pattern

Pending

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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