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Terminated

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

FDA Recall Z-1049-03 · Posted 2003-07-24

Recalling FirmPower Medical Interventions
Recall StatusTerminated
Product CodeGAG
Date Initiated2003-06-30
Date Terminated2004-03-16
Product Quantity767 units

Reason for Recall

latching mechanism failure

Firm 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.

Root Cause

Other

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K003277SURGASSIST SYSTEM WITH CIRCULAR STAPLER DISPOSABLE LOADING UNIT, MODEL CS21,CS25,CS29,CS33Powermed, Inc. · 2000-12-21

Official Source

View FDA Recall →

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

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