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/ Manufacturer |
Exactech, Inc. 2320 NW 66th Ct Gainesville FL 32653-1630
|
For Additional Information Contact |
352-377-1140
|
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.
|