Reported Jul 1, 2020 · Ongoing
HYGENIC Winged Fiesta Kit, Model no. H02778 - Product Usage: The dental dam forceps are intended to be used in…
Coltene Whaledent Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Coltene Whaledent Inc · 235 Ascot Pkwy · Cuyahoga Falls, OH · 44223-3701
Is this the product you have?
- HYGENIC Winged Fiesta Kit, Model no
- H02778 - Product UsageThe 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
- Lot codes and dates
- Batch numbersIf a distributor or end user received one of the batches listed above, they need to look at the batch number laser marked on the forceps themselves. If the forceps has any of the following batch numbers laser marked on them and the forceps do not fit with the dental dam clamps, the forceps should be returned to Coltene
J38382J28715J24868J28716J33647J43944J50980J47108J57802J57061J67133J74174J68563J72691
- Laser marked batch number
1903190419061907190919101911191519201921192319271928193019341940
- Batch numbers
- Amount recalled
- 7,206 forceps
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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