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U.S. Department of Health and Human Services

Class 2 Device Recall Smith & Nephew

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  Class 2 Device Recall Smith & Nephew see related information
Date Initiated by Firm June 19, 2006
Date Posted July 13, 2006
Recall Status1 Terminated 3 on January 10, 2008
Recall Number Z-1227-06
Recall Event ID 35765
510(K)Number K990723  
Product Classification Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
Product TriVex 200LV Resector Kit, 5.5
Part Number: 7209271
Code Information Lot Numbers: All lot numbers lower than 50156900 Expanded recall:  Lot Numbers: 50173181, 50175084
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 sterility seal of the package trays may have incomplete seals compromising the sterility of the device
FDA Determined
Cause 2
Action Smith & Nephew initiated the recall by Certified Letter on June 19, 2006 requesting return of the recalled products. Smith & Nephew expanded the recall to include additional lots. The firm issued the recall expansion letter dated 8/25/06.
Quantity in Commerce 2856 units/Expanded 207 units
Distribution Nationwide and Austria, China, Germany, Finland, Italy, South Africa, South Korea, Switzerland, UK.
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 = GEI and Original Applicant = SMITH & NEPHEW, INC.