Reported Sep 28, 2016 · Terminated
3I OSSEOTITE CERTAIN DENTAL IMPLANTS, 4x11.5 mm, Sterile, Rx only.
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?
- 3I OSSEOTITE CERTAIN DENTAL IMPLANTS, 4x11.5 mm, Sterile, Rx only.
- Lot codes and dates
- Model NoIOSS411
- Lot No2016031461
- UDI(01)00844868007098(17)210401(10)2016031461
- Amount recalled
- 92 units
Where it was sold
Why it was recalled
Product was incorrectly packaged.
This product could cause temporary or reversible health problems — stop using it.
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