Reported Jun 27, 2012 · Terminated
Implant, Dental, Endosseous, Acid Etched, ICE, Osseotite, Internal Connection. . Product is labeled in part:…
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?
- Implant, Dental, Endosseous, Acid Etched, ICE, Osseotite, Internal Connection
- Product is labeled in part"***Certain 3.25, 13***REF IOSM313 LOT*** OSSEOTITE Certain Implant***3.25 x 13mm***CE 0086***Use by yyyy-mm***Sterile by radiation*** STERILE R***Do not re-sterile***RX
- only CautionLaw prohibits dispensing without prescription***do not use if package is damaged***do not reuse***consult instructions for use***Sterile unless package is opened or damaged.***
- Product UsageThe BIOMET 3i Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means of 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
- Lot #2010111529
- Amount recalled
- 219 units in total
Where it was sold
- Nationwide
Why it was recalled
On November 3, 2011 Biomet 3i, Palm Beach Gardens, FL initiated a recall of their Osseotite Certain Implant, Model # IOSM313, Lot #2010111529. Dental implant lot may not have an internal thread.
This product could cause temporary or reversible health problems — stop using it.
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