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HU-FRIEDY MFG. CO., LLC · Model ARDF · UDI-DI 10889950123772

EJG
1
510(k) clearances
11
Adverse events
4
Recalls
105
Facilities

Description

Rubber Dam Forceps

Recalls

DateFirmReason
2020-06-03Coltene Whaledent IncMultiple 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.
2020-06-03Coltene Whaledent IncMultiple 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.
2020-06-03Coltene Whaledent IncMultiple 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.
2020-06-03Coltene Whaledent IncMultiple 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.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.