Reported Nov 25, 2020 · Ongoing
CEI Cutting Edge Instruments (PTC-57C)
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?
- CEI Cutting Edge Instruments (PTC-57C)
- Lot codes and dates
- J88954
- Amount recalled
- 556
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.
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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