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U.S. Department of Health and Human Services

Class 3 Device Recall Exactech Biolox

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  Class 3 Device Recall Exactech Biolox see related information
Date Initiated by Firm November 01, 2007
Date Posted March 12, 2008
Recall Status1 Terminated 3 on May 06, 2012
Recall Number Z-0572-2008
Recall Event ID 45859
510(K)Number K032964  
Product Classification Hip Prosthesis Femoral Head - Product Code LPH
Product Exactech 12/14 Biolox Alumina Femoral Head 28MM +3.5, hip prosthesis component, Exactech, Gainesville, FL 32653
Code Information Lot Number: 474042
Recalling Firm/
Exactech, Inc.
2320 NW 66th Ct
Gainesville FL 32653-1630
For Additional Information Contact
Manufacturer Reason
for Recall
Mislabeled: A ten piece lot of 140-32-03, 12/14 BIOLOXforte Alumina Femoral Heads 32mm (1069020 - 1069029), from Ceramtec were incorrectly labeled as 140-28-03 12/14 BIOLOXforte Alumina Femoral Heads, 28mm
FDA Determined
Cause 2
Process control
Action Exactech issued a recall letter, titled Important Product Recall Notice on 10/31/2007 to the Distibutors that received the recalled product. It requested that all device recipients be notified and all product be returned to the firm.
Quantity in Commerce 10
Distribution Distributed to NY, OH and TN.
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 = LPH and Original Applicant = EXACTECH, INC.