Class 2 Device Recall Smith & Nephew ACUFEX RapPac ACL Accessory Kit

• Date Initiated by Firm: November 08, 2002
• Date Posted: January 09, 2003
• Recall Status: Terminated on April 20, 2005
• Recall Number: Z-0413-03
• Recall Event ID: 25082
• 510(K)Number: K931621
• Product Classification: Arthroscope - Product Code HRX
• Product: Smith & Nephew ACUFEX Rap-Pac ACL Accessory Kit, Sterile; Catalog Number: 014725
• Code Information: Lot Number: 552240
• Recalling Firm/ Manufacturer: Smith & Nephew, Inc.; 130 Forbes Boulevard; Mansfield MA 02048
• For Additional Information Contact: Sally L. Mayer, Esq.; 978-749 Ext. 1492
• Manufacturer Reason for Recall: Potential for non sterility as package tray does not contain aeration holes for ETO processing.
• FDA Determined Cause: Process control
• Action: Smith & Nephew notified customers by letter on 11/8/02. Users are requested to remove stock and return to Smith & Nephew.
• Quantity in Commerce: 77 units
• Distribution: Nationwide: AL, CA, IL, KY, FL, GA, IN, ME, MI, NH,NY, OH, SC, TX, WV,
• 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 = HRX and Original Applicant = ACUFEX MICROSURGICAL, INC.