RecallDepth

SurgAssist System Circular Stapler DLU 33mm

This recall has been terminated (originally issued December 19, 2003).

Company
Power Medical Interventions
Recall Initiated
November 20, 2003
Posted
December 19, 2003
Terminated
February 10, 2004
Recall Number
Z-0253-04
Quantity
350 units
Firm Location
New Hope, PA
Official Source
View on FDA website ↗

Reason for Recall

improper staple formation or anvil jam

Distribution

The 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.

Lot / Code Info

Product Code CS33, Lot numbers LC-000134, LC-000135, LC-000136, LC-000140, and LC-000144.

Root Cause

Other

Action Taken

On 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.

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