Coltene recalls HYGENIC Winged Fiesta Kit model H02778 with batch numbers 1903-1940. Forceps may not fit dental dam clamps due to pin size issues.
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.
Coltene is recalling HYGENIC Winged Fiesta Kit model H02778 because some batches have forceps that don't fit properly with dental dam clamps. This could cause improper use during dental procedures.
The forceps have a pin size larger than acceptable in some batches, making them difficult to fit with dental dam clamps. This could lead to improper placement of dental dams during procedures.
Dental professionals using the HYGENIC Winged Fiesta Kit model H02778 with specific batch numbers. Patients using dental dam procedures may be at risk if improper fitting occurs.
Check the batch number laser marked on the forceps. Affected units have batch numbers: 1903, 1904, 1906, 1907, 1909, 1910, 1911, 1915, 1920, 1921, 1923, 1927, 1928, 1930, 1934, 1940.
Look for the batch number laser marked on the forceps. Affected units have batch numbers 1903 through 1940.
If the forceps have an affected batch number and do not fit with dental dam clamps, return them to Coltene.
Batch numbers 1903, 1904, 1906, 1907, 1909, 1910, 1911, 1915, 1920, 1921, 1923, 1927, 1928, 1930, 1934, 1940.
Check the batch number laser marked on the forceps. If it's one of the listed batch numbers and the forceps don't fit with dental dam clamps, they are affected.
Yes, if the forceps have an affected batch number and do not fit with dental dam clamps, return them to Coltene.
We’ve drafted a message you can send Coltene to request your refund or repair — edit it as you like.
Subject: Recall Z-2421-2020 — Coltene Coltene Hello, I own a Coltene that is covered by recall Z-2421-2020 from Coltene. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
