Reported Mar 19, 2014 · Terminated
Tapered Navigator Certain Surgical Kit Product Usage: Molded plastic tray used in holding various dental instruments…
Biomet 3i, LLC
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: Biomet 3i, LLC · 4555 Riverside Dr · Palm Beach Gardens, FL · 33410-4200
Is this the product you have?
- Tapered Navigator
- Certain Surgical Kit Product UsageMolded plastic tray used in holding various dental instruments for autoclave processing
- Lot codes and dates
- SGTIKIT (SGTTRAY)
- Amount recalled
- 170
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
During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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