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U.S. Department of Health and Human Services

Class 2 Device Recall Total Temporomandibular Joint Replacement System

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  Class 2 Device Recall Total Temporomandibular Joint Replacement System see related information
Date Initiated by Firm September 20, 2013
Date Posted September 02, 2014
Recall Status1 Terminated 3 on October 03, 2014
Recall Number Z-2566-2014
Recall Event ID 67547
PMA Number P020016 
Product Classification Joint, temporomandibular, implant - Product Code LZD
Product Biomet Microfixation Temporomandibular Joint (TMJ) Patient Matched Left Fossa Part# CP751506

The Total Temporomandibular Joint (TMJ) replacement system is implanted in the jaw to functionally reconstruct a diseased and/or damaged temporomandibular joint. The Total TMJ replacement system is a two-component system comprised of mandibular condyle and a glenoid fossa components. Both components are available in multiple stock sizes as right and left specific designs and are attached to the bones by screws.
Code Information Part #CP751506 Lot #478490
Recalling Firm/
Manufacturer		 Biomet Microfixation, LLC
1520 Tradeport Dr
Jacksonville FL 32218-2480
For Additional Information Contact Laura Sabo
904-741-4400
Manufacturer Reason
for Recall		 Product mix occurred prior to final package and labeling process.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action Biomet Microfixation, Inc. sent an Urgent Medical Device Field Notice dated September 20, 2013 to its customer. The customer was instructed to: 1) Immedicately quarantine the device. 2) Discontinue use and return to Biomet Microfixation. 3) If the product was further distributed, the letter must be forwarded to the firm's customers. 4) A replacement device will be shipped priority upon completion. Questions related to this notice should be directed to 904-741-9448 or 904-239-6671. For questions regarding this recall call 904-741-4400.
Quantity in Commerce 1
Distribution Worldwide Distribution to Denmark only.
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.
PMA Database PMAs with Product Code = LZD and Original Applicant = BIOMET MICROFIXATION, INC.
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