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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall Smith & Nephew ACUFEX RapPac ACL Accessory Kit see related information
Date Initiated by Firm November 08, 2002
Date Posted January 09, 2003
Recall Status1 Terminated 3 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/
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 2
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.