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U.S. Department of Health and Human Services

Class 2 Device Recall UCLA Abutment Hexed Castable Cylinder 3.4mm

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  Class 2 Device Recall UCLA Abutment Hexed Castable Cylinder 3.4mm see related information
Date Initiated by Firm July 29, 2015
Date Posted September 11, 2015
Recall Status1 Terminated 3 on May 16, 2016
Recall Number Z-2760-2015
Recall Event ID 72000
510(K)Number K072642  
Product Classification Abutment, implant, dental, endosseous - Product Code NHA
Product UCLA Abutment Hexed Castable Cylinder 3.4mm
Are accessories to endosseous dental implant to support a prosthetic device in a partially or completely edentulous patient.
Code Information Model # MUCC1C LOT # 1186054
Recalling Firm/
Manufacturer		 Biomet 3i, LLC
4555 Riverside Dr
Palm Beach Gardens FL 33410-4200
For Additional Information Contact Customer Service
800-342-5454
Manufacturer Reason
for Recall		 MUCC2, non-hexed, castable abutment cylinders, has been labeled and distributed as a MUCC1C, hexed, castable abutment cylinders for this one lot only.
FDA Determined
Cause 2		 Process control
Action Biomet sent a Medical Device Recall Notice dated July 27, 2015, to all their clinicians informing them about the recall and to complete the attached recall return response form and any unused product to be replaced at no charge. Contact information 1-800-342-5454
Quantity in Commerce 61 pieces
Distribution Worldwide Distribution including Italy and Uruguay.
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 = BIOMET 3I, INC.
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