Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Smith & Nephew

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Smith & Nephewsee related information
Date Initiated by FirmJune 19, 2006
Date PostedJuly 13, 2006
Recall Status1 Terminated 3 on January 10, 2008
Recall NumberZ-1228-06
Recall Event ID 35765
510(K)NumberK990723 
Product Classification Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
Product4.5 mm TRIVEX System Resector Kit (blade and tubing), 3 per box Part Number: 7209514
Code Information Lot Numbers: All lot numbers lower than 50165371 Expanded Recall: Lot Numbers: 50172224, 50173178, 50173179, 50174332, 50174790, 50175034, 50175829, 50175830
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc. Endoscopy Division
150 Minuteman Drive
Andover MA 01810-1031
For Additional Information ContactJason 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
ActionSmith & 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 Commerce5553 units/Expanded 1488 units
DistributionNationwide and Austria, China, Germany, Finland, Italy, South Africa, South Korea, Switzerland, UK.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = GEI
-
-