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U.S. Department of Health and Human Services

Class 2 Device Recall E1 Advantage Head

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 Class 2 Recall
E1 Advantage Head
see related information
Date Posted June 05, 2013
Recall Status1 Terminated on August 29, 2013
Recall Number Z-1465-2013
Recall Event ID 65209
Premarket Notification
510(K) Number
K101336 
Product Classification Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented - Product Code LPH
Product Active Articulation E1. Intended for use with either primary or revision hip arthroplasty.
Code Information Part numbers: EP-200162, EP-200162, EP-200164, and EP-200166 with Lot numbers: 027050, 101470, 115950, 101480, 247990, 948810, 967270, 027070, 287820, 729870, and 860880.
Recalling Firm/
Manufacturer
Biomet, Inc.
56 E Bell Dr
Warsaw, Indiana 46582-6989
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Audrey Daenzer
574-267-6639 Ext. 1676
Manufacturer Reason
for Recall
Biomet is recalling Active Articulation E1 Hip Bearing implants. Biomet has initiated this action following an investigation which identified that outer label indicates two conflicting O.D. sizes while the inner labels indicate an incorrect O.D. size. The implant itself is etched with the correct O.D. size.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Labeling Mix-Ups
Action Biomet sent an Urgent Medical Device Recall letter dated April 26, 2013 to consignees detailing that the outer label indicates two conflicting O.D. sizes while the inner labels indicate an incorrect O.D. size. This action requires the immediate location and discontinued use of the product and its return to Biomet. Ciustomers were advised to: Immediately locate and remove the identified device(s) listed from circulation . -Carefully follow the instructions on the enclosed "FAX Back Response Form" . - Fax a copy of the Response Form to 574-372-1683 prior to return of product. -Use priority carrier for your shipment. - If you have further distributed this product, you MUST notify hospital personnel of this action via the enclosed "Dear O.R. Manager" notice. This letter MUST be given to hospital personnel responsible for receiving recall notices. However, you are charged with the location and return of these products.
Quantity in Commerce 8 units
Distribution Distributed in New York.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LPH and Original Applicant = BIOMET MANUFACTURING CORP.
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