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U.S. Department of Health and Human Services

Class 2 Device Recall SurgASSIST System

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  Class 2 Device Recall SurgASSIST System see related information
Date Initiated by Firm June 30, 2003
Date Posted July 24, 2003
Recall Status1 Terminated 3 on March 16, 2004
Recall Number Z-1048-03
Recall Event ID 26617
510(K)Number K003277  
Product Classification Stapler, Surgical - Product Code GAG
Product SurgASSIST System. Circular Stapler DLU 29 mm (product code CS29)
Code Information Lot numbers DS-000036, DS-000043, DS-000047, DS-000049, DS-000052, DS-000055, DS-000057, DS-000061, DS-000064, DS-000072, DS-000073, DS-000077, DS-000078, DS-000082, DS-000084, DS-000085, DS-000086, DS-000090, DS-000095, DS-000099, DS-000117, DS-000118, DS-000119, DS-000126, DS-000132, DS-000133, DS-000135, DS-000138,  DS-000140, DS-000141, DS-000145, LC-000022, LC-000023, LC-000024, LC-000030, LC-000044, LC-000052, LC-000053, LC-000055, LC-000056, LC-000061, LC-000066, LC-000068, and LC-000074.
Recalling Firm/
Manufacturer		 Power Medical Interventions
110 Union Square Drive
New Hope PA 18938
For Additional Information Contact Emmanuel Tribie
267-775-8156
Manufacturer Reason
for Recall		 latching mechanism failure
FDA Determined
Cause 2		 Other
Action The recalling firm issued a recall letter dated 6/30/03 to their accounts informing them of the recall and the need to return the product.
Quantity in Commerce 4211 units
Distribution The products were shipped to medical facilities and sales representatives nationwide. The products were also shipped to distributors in Belgium, Germany, Ireland, Israel, Italy, Japan, Netherlands, and Spain
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 = GAG and Original Applicant = POWERMED, INC.
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