Class 2 Device Recall Excia Cemented Hip Stems

• Date Initiated by Firm: October 10, 2007
• Date Posted: December 11, 2007
• Recall Status: Terminated on February 07, 2008
• Recall Number: Z-0445-2008
• Recall Event ID: 45456
• 510(K)Number: K042344
• Product Classification: Hip Stems - Product Code LWJ
• Product: Excia Cemented Hip Stems ,Size 18mm, Part Number NJ318K, 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: 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.