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Terminated

SurgAssist System Circular Stapler DLU 33mm

FDA Recall Z-0253-04 · Posted 2003-12-19

Recalling FirmPower Medical Interventions
Recall StatusTerminated
Product CodeGWD
Date Initiated2003-11-20
Date Terminated2004-02-10
Product Quantity350 units

Reason for Recall

improper staple formation or anvil jam

Firm Action

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.

Root Cause

Other

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K032701SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS (CS21, CS25, CS29, CS33)Power Medical Interventions, Inc. · 2003-09-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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