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U.S. Department of Health and Human Services

Class 2 Device Recall Locator Restorative Abutment

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  Class 2 Device Recall Locator Restorative Abutment see related information
Date Initiated by Firm November 23, 2009
Date Posted February 22, 2010
Recall Status1 Terminated 3 on December 15, 2010
Recall Number Z-0810-2010
Recall Event ID 54074
510(K)Number K012911  
Product Classification Endosseous Dental Root-Form Implant - Product Code DZE
Product LOCATOR Restorative Abutment, ILOA002, LOT 877423, Certain LOCATOR ABUTMENT, 4.1 mm(D) X 2mm(H), STERILE Made in USA, Sterile.

BIOMET 3i 4555 Riverside Drive, Palm Beach Gardens, FL 33410 USA.

For use on tissue supported removable over-dentures on 2 to 4 implants, partially edentulous overdentures with one or more implants, limited interarch distance, angle correction with up to 40 degrees between divergent implants.
Code Information Lot 877423
Recalling Firm/
Manufacturer		 Biomet 3i, LLC
4555 Riverside Dr
Palm Beach Gardens FL 33410-4200
For Additional Information Contact Kelly Taylor
561-776-6700
Manufacturer Reason
for Recall		 Package labeled as sterile may have an incomplete or partial seal thereby possibly compromising sterility.
FDA Determined
Cause 2		 Process control
Action Each US customer will be contacted by telephone using a prepared phone script. Following telephone contact, Biomet 3i will perform a follow-up of each call with a faxed letter. The Urgent: Medical Device Recall letter, dated 11/23/2009, identified the affected product and asked customers to return unused product for replacement. The letter also explained the clinical implications and asked customers to respond with the attached response fax and then return the abutment(s) to BIOMET 3i. Questions or concerns can be directed to Kelly Taylor at 561-776-6906.
Quantity in Commerce 97
Distribution Worldwide Distribution -- USA, Middle East, Italy, Europe, and Greece.
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 = DZE and Original Applicant = IMPLANT INNOVATIONS, INC.
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