Events

Recall of Device Recall Allen Medical

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

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
    31329
  • Event Risk Class
    Class 2
  • Event Number
    Z-0722-05
  • Event Initiated Date
    2005-03-04
  • Event Date Posted
    2005-04-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-05-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37683
  • 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
    Operating Room Accessories Table Tray - Product Code FWZ
  • Reason
    Shoulder positioner may break near the rail that attaches to the operating table.
  • Action
    Allen Medical notified consignees by letter dated 3/4/05 via Fed''X. Facilities are requested to remove the shoulder positioner and return it per the listed instructions .

Device

Device Recall Allen Medical
  • Model / Serial
    Serial Numbers:  260227 260228 260229 260230 262208 A032121 A032122 A032123 A032124 A032125 A032126 A032128 A032129 A032340 A032942 A032944 A033038 A033039 A033040 A033920 A033921 A033922 A033923 A033924 A033925 A033927 A033928 A033929 A034241 A034242 A034243 A034623 A034624 A034626 A034627 A034628 A034877 A034907 A034909 A035239 A035242 A035243 A035623 A035624 A035625 A037489 A040087 A040359 A040360 A040361 A040362 A040363 A040364 A040650 A040693 A040694 A040778 A040779 A040780 A040781 A040782 A041742 A041743 A041744 A041745 A041746 A041747 A042080 A042081 A042082 A042159 A042533 A042534 A042640 A042641 A043683 A043684 A043953
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Foreign: Australia, Greece, Italy, Ireland
  • Product Description
    Allen A-91000 Shoulder Positioner
  • Manufacturer
    Allen Medical Systems

Manufacturer

Allen Medical Systems
  • Manufacturer Address
    Allen Medical Systems, One Post Office Square, Acton MA 01720-3934
  • Source
    USFDA