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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 3.4mmsee related information
Date Initiated by FirmJuly 29, 2015
Date PostedSeptember 11, 2015
Recall Status1 Terminated 3 on May 16, 2016
Recall NumberZ-2760-2015
Recall Event ID 72000
510(K)NumberK072642 
Product Classification Abutment, implant, dental, endosseous - Product Code NHA
ProductUCLA 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 ContactCustomer 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
ActionBiomet 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 Commerce61 pieces
DistributionWorldwide Distribution including Italy and Uruguay.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = NHA
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