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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 October 17, 2014
Date Posted December 16, 2014
Recall Status1 Terminated 3 on January 04, 2017
Recall Number Z-0520-2015
Recall Event ID 69644
PMA Number P020016 
Product Classification Joint, temporomandibular, implant - Product Code LZD
Product Total Temporomandibular Joint Replacement System- 55mm Rt Standard Ti Mand
Reconstruction of the temporomandibular joint
Code Information Model 24-6555TI, Lot #s: 525210B, 525200A, 525200B, 525210A.
Recalling Firm/
Manufacturer		 Biomet Microfixation, LLC
1520 Tradeport Dr
Jacksonville FL 32218-2480
For Additional Information Contact Rachel Osbeck
904-741-4400
Manufacturer Reason
for Recall		 Laser etching on the parts is wider and deeper than the conditions previously validated.
FDA Determined
Cause 2		 Software Design Change
Action BIOMET sent an Urgent Medical Device Recall letter dated October 17, 2014 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to take the following steps: 1) Immediately locate and remove from circulation the items invoiced/consigned/loaned to your account. 2) Carefully follow the instructions on the enclosed "Response Form." and 3)If you have further distributed these items to medical facilities, you must notify them of this action. For questions customers were instructed to call 1-800-874-7711 or 904-741-4400, extension 9448, Monday through Friday, 8 a.m. to 4 p.m. EST. For questions regarding this recall call 904-741-9448.
Quantity in Commerce 42
Distribution Worldwide Distribution - USA including PA, MN, CA and Internationally to Australia, Netherlands, France, and United Kingdom.
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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