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U.S. Department of Health and Human Services

Class 3 Device Recall Certain PreFormance

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  Class 3 Device Recall Certain PreFormance see related information
Date Initiated by Firm October 08, 2007
Date Posted January 17, 2008
Recall Status1 Terminated 3 on July 10, 2008
Recall Number Z-0128-2008
Recall Event ID 45431
510(K)Number K060291  
Product Classification Dental Implant - Product Code NHA
Product Biomet 3i, Certain PreFormance Temporary Cylinder, Catalog Number: IPFTC42, Dental Implant, Biomet 3i, Palm Beach Gardens, FL 33410
Code Information Lot Number: 707303, Expiration Date: 08/31/2012
Recalling Firm/
Manufacturer		 Biomet 3i
4555 Riverside Dr
Palm Beach Gardens FL 33410-4200
For Additional Information Contact
561-776-6700 Ext. 6819
Manufacturer Reason
for Recall		 Incorrect assembly: The product does not allow for the screw to pass through the access hole and engage the implant properly. Therefore, the provisional restoration will not be seated on the implant platform.
FDA Determined
Cause 2		 Process control
Action Beginning on 9/27/07, Biomet 3i contacted its US consignees by telephone using a prepared script. Following telephone contact, Biomet 3i sent a recall letter, titled Urgent Medical Device Recall, by fax. The international consignees were contacted by email followed by a faxed letter. Each customer was requested to examine their inventory for the affected part and corresponding lot number, and return them to Biomet 3i.
Quantity in Commerce 114
Distribution Worldwide Distribution - USA, Italy, France, Spain and UK.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NHA and Original Applicant = IMPLANT INNOVATIONS, INC.
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