Class 2 Device Recall SurgASSIST System

• Date Initiated by Firm: June 30, 2003
• Date Posted: July 24, 2003
• Recall Status: Terminated on March 16, 2004
• Recall Number: Z-1049-03
• Recall Event ID: 26617
• 510(K)Number: K003277
• Product Classification: Stapler, Surgical - Product Code GAG
• Product: SurgASSIST System. Circular Stapler DLU 33 mm (product code CS33).
• Code Information: Lot numbers DS-000122, DS-000123, DS-000127, DS-000134, DS-000139, DS-000142, DS-000146, and DS-000148.
• 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: 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: 767 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