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U.S. Department of Health and Human Services

Class 2 Device Recall Excia Cemented Hip Stems

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  Class 2 Device Recall Excia Cemented Hip Stems see related information
Date Initiated by Firm October 10, 2007
Date Posted December 11, 2007
Recall Status1 Terminated 3 on February 07, 2008
Recall Number Z-0441-2008
Recall Event ID 45456
510(K)Number K042344  
Product Classification Hip Stems - Product Code LWJ
Product Excia Cemented Hip Stems, Size 14mm, Part Number : NJ314K, Aesculap Implant Systems, Inc., Center Valley, PA 18034
Code Information All Lot Numbers
Recalling Firm/
Manufacturer
Aesculap Implant Systems
3773 Corporate Pkwy
Center Valley PA 18034-8217
For Additional Information Contact Michael Andrews
800-258-1946
Manufacturer Reason
for Recall
Sterility (package integrity) Compromised: Device package damaged during shipment
FDA Determined
Cause 2
Package design/selection
Action The recalling firm issued an Important Recall Notice letter dated 10/10/07 to all their customers informing them of the problem and the need to return the product.
Quantity in Commerce 167 units
Distribution Nationwide-USA including states of AZ, GA, MD, OK, PA, TX, and VA (distributors) medical facilities in FL, NY, and PA; and sales representatives in CA and FL.
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 = LWJ and Original Applicant = AESCULAP, INC.
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