The Food and Drug Administration (FDA) warns all healthcare professionals and establishments on the voluntary recall of affected batches of HYGENIC® Dental Dam Forceps p/n H01262 that may have been sold as part of Hygenic Simple Dam Kit™, p/n 60019066, Hygenic Winged Fiesta Kit™, p/n H02778 and Hygenic Wingless Fiesta Kit™, p/n H02790, manufactured by Coltene/Whaledent, Inc. and imported by Dent1st Corp. The following batches are affected by this recall:
| Forceps
Batches (H01262) |
Simple Dam Kit
(60019066) |
Winged (H02778) | Wingless (H02790) |
| J16743 | J73571 | J38382 | J74546 |
| J16745 | J28715 | J74184 | |
| J29784 | J24868 | ||
| J31289 | J28716 | ||
| J33607 | J33647 | ||
| J44177 | J43944 | ||
| J44178 | J50980 | ||
| J44840 | J47108 | ||
| J47109 | J57802 | ||
| J47110 | J57061 | ||
| J49167 | J67133 | ||
| J67132 | J74174 | ||
| J73572 | J68563 | ||
| J73785 | J72691 | ||
| J74711 |
Multiple batches of the abovementioned medical device were identified to have a pin size larger than the acceptable size. This larger pin size may make it difficult for the forceps to fit appropriately with the HYGENIC branded or Fiesta branded dental dam clamps. There are no safety concerns to the patient or user as the larger sized pins on the forceps render the forceps unusable.
In light of the foregoing, all concerned healthcare professional, establishment, and the general public is warned to discontinue further use, sale, and distribution of the above mentioned medical device.
All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that product is not sold or made available in the market or areas of jurisdiction.
To report any sale or distribution of unregistered medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.
Any suspected adverse reaction experienced from the use of the medical device but not limited to the lot numbers stated above should be reported immediately to FDA.
For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health, and Research through e-mail at [email protected], or call (02) 857-1900 loc. 8301.
Dissemination of this advisory to all concerned is hereby requested.
Table 1. Affected batches of HYGENIC® Dental Dam Forceps p/n H01262
All concerned healthcare professionals and establishments are advised to check the laser marked batch number on the forceps. If the laser marked batch number on the forceps matches one of the number listed below, the said forceps must be returned to Dent1st Corp.
| 1903 | 1909 | 1920 | 1928 |
| 1904 | 1910 | 1921 | 1930 |
| 1906 | 1911 | 1923 | 1934 |
| 1907 | 1915 | 1927 | 1940 |
Multiple batches of the abovementioned medical device were identified to have a pin size larger than the acceptable size. This larger pin size may make it difficult for the forceps to fit appropriately with the HYGENIC branded or Fiesta branded dental dam clamps. There are no safety concerns to the patient or user as the larger sized pins on the forceps render the forceps unusable.
In light of the foregoing, all concerned healthcare professional, establishment, and the general public is warned to discontinue further use, sale, and distribution of the above mentioned medical device.
All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that product is not sold or made available in the market or areas of jurisdiction
To report any sale or distribution of unregistered medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.
Attachment:-> FDA-Advisory-No.2020-1808