Recall Z-2422-2020 ยท EJG Forceps, Rubber Dam Clamp
Coltene Whaledent Inc
HYGENIC Wingless Fiesta Kit, Model no. H02790 - 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.
| Date | Jun 3, 2020 |
| Status | Open, Classified |
| 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. |
| Root cause | 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: Tr |
| Quantity | 7,206 forceps |
| Distribution | Pending |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.