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U.S. Department of Health and Human Services

Class 2 Device Recall Osseotite NT Certain

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 Class 2 Recall
Osseotite NT Certain
see related information
Date Posted May 24, 2011
Recall Status1 Terminated on January 25, 2012
Recall Number Z-2245-2011
Recall Event ID 58328
Premarket Notification
510(K) Number
K063341 
Product Classification Dental Implant Surgical Tray (Kit) - Product Code OFY
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.
Code Information Lot #963841
Recalling Firm/
Manufacturer
Biomet 3i, LLC
4555 Riverside Dr
Palm Beach Gardens, Florida 33410-4200
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Alfredo Ferrer
561-776-6700
Manufacturer Reason
for Recall
Biomet 3i is recalling their product Osseotite NT Certain Dental Implant INT411 . The internal thread was not manufactured correctly.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action 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.
Quantity in Commerce 236
Distribution Worldwide Distribution - USA (nationwide) and the countries of Europe, Japan, Asia, and South America.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = OFY and Original Applicant = IMPLANT INNOVATIONS, INC.
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