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U.S. Department of Health and Human Services

Class 2 Device Recall Smith & Nephew

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 Class 2 Recall
Smith & Nephew
see related information
Date Posted April 07, 2007
Recall Status1 Terminated on July 14, 2008
Recall Number Z-0726-2007
Recall Event ID 37582
Product Classification System, Test, Blood Glucose, Over The Counter - Product Code NBW
Product Smith & Nephew Suture Passer 2 inch Part Number : 7209167
Code Information All lot codes
Recalling Firm/
Manufacturer
Smith & Nephew, Inc. Endoscopy Division
150 Minuteman Drive
Andover, Massachusetts 01810-1031
For Additional Information Contact Jason Bilobram
978-474-6332
Manufacturer Reason
for Recall
Product is labeled as reusable but there is a potential that the cannulated handle of the product cannot be cleaned adequately following use.
FDA Determined
Cause 2
DESIGN: Device Design
Action Smith & Nephew notified accounts by letter on 3/1/07, users are advised to destroy product and return unused product in their inventory. A reply form is required to be completed.
Quantity in Commerce 12, 292 units for all recalls Z-0724-0726-07
Distribution World wide- USA and Canada, Belgium. Germany, Denmark, Spain, Finland, France, Great Britain, Greece, Italy, Netherlands, Portugal, Austria, Ireland, Sweden, Argentina. Chile, Columbia, Brazil, China. Japan, Korea, Thailand, Hong Kong, Malaysia. Taiwan, Singapore, India, , Dubai, Mexico, Australia, Egypt. Switzerland, New Zealand and Norway
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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