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Terminated

Power Linear Cutter Reusable Digital Loading Units with Reloads. Common name - Implantable staple. Model number PLC60

FDA Recall Z-1099-2007 · Posted 2007-07-24

Recalling FirmPower Medical Interventions, Inc
Recall StatusTerminated
Product CodeGDW
Date Initiated2007-05-12
Date Terminated2007-08-29
Product Quantity9 units

Reason for Recall

Malfunction - improper staple formation

Firm Action

The field sales representatives were telephoned 5/14/2007, and instructed to return the affected devices from the customer sites.

Root Cause

Other

Distribution Pattern

The products were shipped to medical facilities in DC, FL, GA, and NY. The product was also shipped to Germany

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K052415POWER LINEAR CUTTER REUSABLE DIGITAL LOADING UNITS WITH RELOADSPower Medical Interventions, Inc. · 2005-09-29

Official Source

View FDA Recall →

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

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