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U.S. Department of Health and Human Services

Class 2 Device Recall 3i Custom

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  Class 2 Device Recall 3i Custom see related information
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
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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