Date Initiated by Firm |
December 11, 2006 |
Date Posted |
September 22, 2009 |
Recall Status1 |
Terminated 3 on October 01, 2009 |
Recall Number |
Z-2227-2009 |
Recall Event ID |
52631 |
510(K)Number |
K072642
|
Product Classification |
Endosseous dental implant abutment - Product Code NDA
|
Product |
3i Custom # 5753, OSCM2913, 2.9MMX 3.4MM X 13MM, OSSEOTITE CUSTOM, MICROMINI IMPLANT, LOT # 470258, Sterile. Implant Innovations, Inc. 4555 Riverside Drive, Palm Beach Gardens, FL 33410.
Custom temporary cover screws are for use in maintaining the soft tissue during the healing process of a dental restoration. |
Code Information |
Lot # 51298 |
Recalling Firm/ Manufacturer |
Biomet 3i, LLC 4555 Riverside Dr Palm Beach Gardens FL 33410-4200
|
For Additional Information Contact |
Alfredo Ferrer 561-776-6706
|
Manufacturer Reason for Recall |
Healing Abutment was not made within required manufacturing specification. The product did not have the relief behind the thread, which does not allow proper seating.
|
FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
Each of the US customers was contacted by phone. Following the phone contacts, Biomet 3i performed a follow- up of each call with a faxed letter. Each customer was instructed to check their respective inventory for the affected product and corresponding lot number. They were then requested to fax back a response form to Biomet 3i Regulatory Services to provide feedback concerning their inventory. They were also instructed to return the affected product to Biomet 3i. Contact Biomet 3i, LLC at 1.561.776.6706, if there are any questions. |
Quantity in Commerce |
24 |
Distribution |
USA and Italy |
Total Product Life Cycle |
TPLC Device Report
|
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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 = NDA and Original Applicant = BIOMET 3I, INC.
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