—#98995

Product

***REF INT411***OSSEOTITE Tapered Certain Implant 4 x 11.5mm***Sterile Using Radiation***Rx Only***BIOMET 3i Dental lberica S.L.WTC Almeda Park, Ed, 1 Planta 1 Pl. de la Pau s/n08940 Cornella de Llobregat (Barcelona) Spain***Phone +34 934-705-500; Fax +34 933-717-849. 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.

FDA product code: O-FY
Affected lot / code info: Lot #963841

Why it was recalled

Biomet 3i is recalling their product Osseotite NT Certain Dental Implant INT411 . The internal thread was not manufactured correctly.

Root cause (FDA determination)

Other

Action the firm took

Biomet 3i, LLC sent an Urgent Medical Device Recall letter dated March 14, 2011, via email or fax to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. A small percentage of the implant lots may have a condition affecting the internal thread. The condition, if present, will prevent the cover screw, temporary healing abutment, final restorative abutment, etc. from engaging the implant. Customers were instructed to contact Customer Service at 1-800-342-5454 if this condition is recognized upon attempting to assemble any of the screws with the implant. Customers were instructed to return the implant to the firm for replacement to the following address: BIOMET 3i Regulatory Compliance Department 4555 Riverside Drive Palm Beach Gardens, Florida 33410 Incident No. CC117886 Customers were also instructed to respond with the attached Response Fax or email to DomesticComplaints@Biomet.com. For any questions regarding this recall call 561-776-6906.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) and the countries of Europe, Japan, Asia, and South America.

Timeline

Recall initiated: 2011-03-10
Posted by FDA: 2011-05-24
Terminated: 2012-01-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #98995. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.