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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/
Manufacturer
Smith & Nephew, Inc. Endoscopy Division
150 Minuteman Drive
Andover MA 01810-1031
For Additional Information Contact Jason Bilobram
978-474-6332
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
Other
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.
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