—#110364

Product

***REF IFNT611***Full OSSEOTITE Tapered Certain Implant 6 x 11.5mm***Sterile by radiation***Rx Only***BIOMET 3i Dental Iberica S.L. WTC Almeda Park, Ed, 1, Planta 1 Pl. de la Pau s/n08940 Cornella de Llobregat (Barcelona) Spain. Lot #2011110798. 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 endentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridge work and to retain over dentures.

FDA product code: NHA — Abutment, Implant, Dental, Endosseous
Device class: Class 2
Medical specialty: Dental
510(k) numbers: K063341
Affected lot / code info: Lot Number 2011110798

Why it was recalled

Biomet 3i is recalling their product Full Osseotite Tapered Certain Implant IFNT611. The depth of the implant's internal hex is too shallow. The condition, if present, may prevent the driver; cover screw or abutment from fully engaging the implant.

Root cause (FDA determination)

Process control

Action the firm took

BIOMET 3i sent an Urgent Medical Device Recall letter on March 19, 2012, to all affected customers via email or fax. The letter identified the product, the problem, and the action to be taken by the customer. Customers are to return any unopened and unused product for replacement at no cost. In addition, customers should contact Customer Service at 1-800-342-5454 for assistance if they encounter issues with the mating component, or if they have any questions or concerns. Customers are to respond to the notification regardless of whether they have product to return.

Recalling firm

Firm: Biomet 3i, LLC
Address: 4555 Riverside Dr, Palm Beach Gardens, Florida 33410-4200

Distribution

Distribution pattern: Worldwide Distribution -- United States, UK, France, Canada, Mexico, Poland, Lebanon and Hong Kong.

Timeline

Recall initiated: 2012-03-23
Posted by FDA: 2012-08-08
Terminated: 2013-12-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #110364. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.