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
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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.
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PMA Database |
PMAs with Product Code = LZD and Original Applicant = BIOMET MICROFIXATION, INC.
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