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U.S. Department of Health and Human Services

Class 2 Device Recall Smith & Nephew FASTFIX

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  Class 2 Device Recall Smith & Nephew FASTFIX see related information
Date Initiated by Firm March 24, 2006
Date Posted April 26, 2006
Recall Status1 Terminated 3 on December 12, 2007
Recall Number Z-0798-06
Recall Event ID 35033
510(K)Number K020480  
Product Classification Retention Device, Suture - Product Code KGS
Product FAST-FIX AB Curved Needle Delivery System, Used for meniscal repair.
Product Number: 7209399
Code Information Lot Numbers: 50141993, 50145519, 50146091,50146096, 50146362, 50148283, 50146365, 50153066, 50150381
Recalling Firm/
Smith & Nephew, Inc. Endoscopy Division
150 Minuteman Drive
Andover MA 01810-1031
For Additional Information Contact Jason Bilobram
Manufacturer Reason
for Recall
The implant consists of a T1 and T2 anchor which are joined together by a suture. The T2 portion of the implant may not advance into the deployment position preventing deployment of the T2 anchor.
FDA Determined
Cause 2
Action Smith & Nephew notified accounts by letter dated 3/24/06 issued by Federal Express. Users are requested to return product.
Quantity in Commerce 1800 units
Distribution Nationwide Foreign: Austria, Germany, France, Italy, Australia
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 = KGS and Original Applicant = SMITH & NEPHEW, INC.