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Class 2 Device Recall SurgASSIST System |
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Date Initiated by Firm |
June 30, 2003 |
Date Posted |
July 24, 2003 |
Recall Status1 |
Terminated 3 on March 16, 2004 |
Recall Number |
Z-1049-03 |
Recall Event ID |
26617 |
510(K)Number |
K003277
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Product Classification |
Stapler, Surgical - Product Code GAG
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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
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For Additional Information Contact |
Emmanuel Tribie 267-775-8156
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Manufacturer Reason for Recall |
latching mechanism failure
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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 |
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
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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.
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510(K) Database |
510(K)s with Product Code = GAG and Original Applicant = POWERMED, INC.
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