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U.S. Department of Health and Human Services

Class 2 Device Recall DISCOVERY ELBOW

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  Class 2 Device Recall DISCOVERY ELBOW see related information
Date Initiated by Firm May 15, 2014
Date Posted June 26, 2014
Recall Status1 Terminated 3 on March 16, 2015
Recall Number Z-1925-2014
Recall Event ID 68418
510(K)Number K013042  
Product Classification Prosthesis, elbow, constrained, cemented - Product Code JDC
Product DISCOVERY ELBOW prosthesis, 4 MM X 100 MM RIGHT HUMERAL FLANGED I BOND COAT Tl 6AL 4V ALLOY.

Elbow joint replacement prostheses are intended for primary and revision joint arthroplasty for use in cemented applications.
Code Information Catalog/REF #: 114905, Lot #: M846640
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact Ms. Audrey E. Daenzer
574-267-6639 Ext. 1676
Manufacturer Reason
for Recall		 Surface finish is different than specified. The implant has 30 grit blast on the exterior of the flange when the print calls for the glass bead blast. The patient may experience pain requiring surgical intervention.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Biomet sent an Urgent Medical Device Recall Notice letter dated May 28, 2014 to their customer. The letter identified the affected product, problem and actions to be taken. The letter instructed physician to monitor the patient for any pain that may require surgical intervention. For questions call (574) 372-1570.
Quantity in Commerce 1
Distribution US Nationwide Distribution in the state of California
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 ORTHOPEDICS, INC.
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