Reported Oct 31, 2012 · Terminated
Osseotite Tapered Certain Implant 5 X 10mm Model INT510 Biomet 3i Dental Implants are intended for surgical placement…
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?
- Osseotite Tapered Certain Implant 5 X 10mm Model INT510 Biomet 3i Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridgework and to retain over dentures.
- Lot codes and dates
Model # INT510Lot # 2011090751
- Amount recalled
- 227
Where it was sold
Why it was recalled
Biomet 3i recalled their Osseotite Tapered Certain Implant, Model # INT510 due to a small percentage of the devices are missing the internal threading.
This product could cause temporary or reversible health problems — stop using it.
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