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U.S. Department of Health and Human Services

Class 2 Device Recall SurgAssist System Circular Stapler DLU 29mm

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  Class 2 Device Recall SurgAssist System Circular Stapler DLU 29mm see related information
Date Initiated by Firm November 20, 2003
Date Posted December 19, 2003
Recall Status1 Terminated 3 on February 10, 2004
Recall Number Z-0252-04
Recall Event ID 27764
510(K)Number K032701  
Product Classification Indirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp - Product Code GWD
Product SurgAssist System Circular Stapler DLU 29mm
Code Information Product Code CS29, Lot numbers LC-000125, LC000126, LC-000127, LC-000131, LC-000132, LC-000133, LC-000137, LC-000139, LC-000139-1, LC-000142, and LC-000143.
Recalling Firm/
Power Medical Interventions
110 Union Square Dr
New Hope PA 18938-1365
For Additional Information Contact Emmanuel Tribie
Manufacturer Reason
for Recall
improper staple formation or anvil jam
FDA Determined
Cause 2
Action On 11/20/03, the recalling firm sent recall notices via overnight carrier to all customers who have been shippped and/or sold the product. The recall notice requested the return of the devices.
Quantity in Commerce 1164 units
Distribution The products were shipped to medical facilities and sales representatives nationwide. The product was also shipped to distributors in the United Kingdom, France, Scotland, Belgium, Germany, Israel, Italy, Japan, Spain, Portugal, and Sweden.
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 = GWD and Original Applicant = POWER MEDICAL INTERVENTIONS, INC.