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U.S. Department of Health and Human Services

Class 2 Device Recall Novation Element

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  Class 2 Device Recall Novation Element see related information
Date Initiated by Firm September 23, 2015
Date Posted November 02, 2015
Recall Status1 Terminated 3 on March 01, 2017
Recall Number Z-0201-2016
Recall Event ID 72357
510(K)Number K080980  
Product Classification Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate - Product Code MEH
Product Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset, Size 9, Femoral Hip Implant Stems, Intended for press-fit fixation
Code Information Catalog Number 164-13-09 Serial Numbers: 4076815, 4076816, 4076817, 4076818, 4076819, 4076820, 4076821, and 4076822.
Recalling Firm/
Manufacturer		 Exactech, Inc.
2320 NW 66th Ct
Gainesville FL 32653-1630
For Additional Information Contact Kaya Davis
800-392-2832
Manufacturer Reason
for Recall		 Eight (8) pieces did not receive the specified Hydroxyapatite (HA) coating.
FDA Determined
Cause 2		 Under Investigation by firm
Action The firm, Exactech, issued an "IMPORTANT NOTIFICATION-PRODUCT RECALL ADVISORY NOTICE" dated September 23, 2015, by phone and by mail to their consignees. The notice described the product, problem and actions taken. The consignees were instructed to 1) Immediately cease distribution or use of these products. 2) Extend this information to your accounts that may have this product in their possession. 3) Identify and quarantine any of the subject Novation Element Pres Fit Femoral stem in your inventory. 4) Complete and Return the attached Recall Inventory Response Form to Exactech,per the instructions provided on the notice itself, within 5 business days, via fax to: 352-337-3915 or email kaya@exac.com. Return products to: Exactech Distribution Center, 2411 NW 66th Court, Gainesville, Florida 32653, Attention: Exactech inventory representative. Any questions contact your Exactech inventory representative at kaya@exac.com or 1-800-392-2832.
Quantity in Commerce 8
Distribution US Distribution to states of: AZ, CO, FL, and MD.
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 = MEH and Original Applicant = EXACTECH, INC.
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