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U.S. Department of Health and Human Services

Class 2 Device Recall SurgAssist System Circular Stapler DLU 33mm

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 Class 2 Device Recall SurgAssist System Circular Stapler DLU 33mmsee related information
Date Initiated by FirmNovember 20, 2003
Date PostedDecember 19, 2003
Recall Status1 Terminated 3 on February 10, 2004
Recall NumberZ-0253-04
Recall Event ID 27764
510(K)NumberK032701 
Product Classification Indirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp - Product Code GWD
ProductSurgAssist System Circular Stapler DLU 33mm
Code Information Product Code CS33, Lot numbers LC-000134, LC-000135, LC-000136, LC-000140, and LC-000144.
Recalling Firm/
Manufacturer
Power Medical Interventions
110 Union Square Dr
New Hope PA 18938-1365
For Additional Information ContactEmmanuel Tribie
267-775-8100
Manufacturer Reason
for Recall
improper staple formation or anvil jam
FDA Determined
Cause 2
Other
ActionOn 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 Commerce350 units
DistributionThe 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 CycleTPLC 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) Database510(K)s with Product Code = GWD
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