Events

Recall of Device Recall Power Linear Cutter Reusable Digital Loading Units with Reloads

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Power Medical Interventions, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    37982
  • Event Risk Class
    Class 2
  • Event Number
    Z-1099-2007
  • Event Initiated Date
    2007-05-12
  • Event Date Posted
    2007-07-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-08-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=52591
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    surgical staple - Product Code GDW
  • Reason
    Malfunction - improper staple formation.
  • Action
    The field sales representatives were telephoned 5/14/2007, and instructed to return the affected devices from the customer sites.

Device

Device Recall Power Linear Cutter Reusable Digital Loading Units with Reloads
  • Model / Serial
    Model number PLC60. Serial numbers: DO6E0133, DO6E253, DO6E173, DO6E233, DO6E223, DO6E383, DO6G0093, DO6E0043, and DO6E0013.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    The products were shipped to medical facilities in DC, FL, GA, and NY. The product was also shipped to Germany
  • Product Description
    Power Linear Cutter Reusable Digital Loading Units with Reloads. Common name - Implantable staple. Model number PLC60
  • Manufacturer
    Power Medical Interventions, Inc

Manufacturer

Power Medical Interventions, Inc
  • Manufacturer Address
    Power Medical Interventions, Inc, 2021 Cabot Blvd W, Langhorne PA 19047-1810
  • Source
    USFDA