Z-1049-03

SurgASSIST System. Circular Stapler DLU 33 mm (product code CS33)

Name: Z-1049-03 SurgASSIST System. Circular Stapler DLU 33 mm (product code CS33)
Creator: Power Medical Interventions
Published: 2003-06-30
License: https://open.fda.gov/license/

Power Medical Interventions, Inc. / initiated 2003-06-30 / Terminated

FDA source

Power Medical Interventions began a recall of SurgASSIST System. Circular Stapler DLU 33 mm (product code CS33) on 2003-06-30. The reason FDA records is "latching mechanism failure". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1049-03
Status: Terminated
Initiated: 2003-06-30
Posted: 2003-07-24
Terminated: 2004-03-16
Recalling firm: Power Medical Interventions, Inc.
Product: SurgASSIST System. Circular Stapler DLU 33 mm (product code CS33).
Product code: GAG Stapler, Surgical
Reason for recall: latching mechanism failure
FDA root 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
Product codes and lots: Lot numbers DS-000122, DS-000123, DS-000127, DS-000134, DS-000139, DS-000142, DS-000146, and DS-000148.

Product code GAG

K003277Class IISurgassist System with Circular Stapler Disposable Loading Unit, Model Cs21,cs25,cs29,cs33Powermed, Inc. / cleared 2000-12-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)