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U.S. Department of Health and Human Services

Class 2 Device Recall Discovery Elbow System Humeral Condyle Set Hexalobular

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  Class 2 Device Recall Discovery Elbow System Humeral Condyle Set Hexalobular see related information
Date Initiated by Firm December 14, 2011
Date Posted February 21, 2012
Recall Status1 Terminated 3 on December 12, 2012
Recall Number Z-1071-2012
Recall Event ID 60971
510(K)Number K051975  
Product Classification Prosthesis, elbow, constrained, cemented - Product Code JDC
Product Discovery Elbow System Humeral Condyle Set- Hexalobular, REF 114700, Lot 797550 Alloy, Sterile, Biomet Orthopedics Warsaw IN 46581.

Intended for primary and revision joint arthroplasty for use in cemented applications.
Code Information REF 114700, Lot 797550
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact Angie Dickson
574-267-6639
Manufacturer Reason
for Recall		 A Discovery Condyle Kit w/ Hexalobula was opened during an elbow joint replacement surgery, and was found to contain two male condyles.
FDA Determined
Cause 2		 Process change control
Action December 14, 2011 Urgent Medical Device Recall Notices were sent to Distributors and hospital OR managers describing the product, problem, risks associated with the recall, and actions to be taken. The notice included Instructions to locate and remove the product. Customers were asked to complete a response form and fax to 574-372-1683, prior to returning product by priority mail to the attention of Angi Dickson, Biomet , 56 East Bell Drive Warsaw, IN, USA 46580 with a copy of the response form. Receipt of the notice should also be confirmed by calling 800-348-9500, extension 3983 or 3009. Questions related to this notice should be directed to 574-371-3983 or 574-371-3009 Monday through Friday 8 AM to 5 PM.
Quantity in Commerce 10 units
Distribution International Only Distribution -- Netherlands & UK.
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 = JDC and Original Applicant = BIOMET, INC.
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