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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 March 01, 2007
Date Posted April 07, 2007
Recall Status1 Terminated 3 on July 14, 2008
Recall Number Z-0725-2007
Recall Event ID 37582
Product Classification Suture Passer - Product Code NBW
Product Smith & Nephew Suture Passer 12 inch
Part Number 7209166D (refurbished)
Code Information All lot codes
Recalling Firm/
Smith & Nephew, Inc. Endoscopy Division
150 Minuteman Drive
Andover MA 01810-1031
For Additional Information Contact Jason Bilobram
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
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 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.