Events

Recall of Device Recall Arthrex Shoulder Suspension Tower

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Allen Medical Systems, 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
    76257
  • Event Risk Class
    Class 2
  • Event Number
    Z-1198-2017
  • Event Initiated Date
    2017-01-03
  • Event Date Posted
    2017-02-14
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152596
  • 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
    Apparatus, traction, non-powered - Product Code HST
  • Reason
    During use, there is a potential scenario which could allow the fastening screws attaching covers to come loose and potentially land in the sterile field causing a delay in surgery.
  • Action
    The distributor was notified of the recall via email on January 3, 2017. The letter identified the affected product, problem and actions to be taken. The letter instructs the consignee to remove the product from service and follow instructions to return the device to Allen Medical for repair.

Device

Device Recall Arthrex Shoulder Suspension Tower
  • Model / Serial
    Serial Numbers: 501798, 501799, 501800, 501801, 501802, 501803, 501804, 501805, 501806, 501807, 501808, 501809, 501810, 501811, 501812, 501813, 501814, 501815, 501816, 501817, 501818, 501819, 501820, 501821, 501822, 501823, 501824, 501825, 501826, 501827, 501828, 501829, 501830, 501831, 501832, 501833, 501834, 501835, 501836, 501837, 501838, 501839, 501840, 501841, 501842, 501848, 501849, 501850, 501851, 501852, 501853, 501854, 501855, 501856, 501857, 501863, 501864, 501865, 501866, 501867, 501868, 501869, 501870, 501871, 501872, 501878, 501879, 501880, 501881, 501882, 501883, 501884, 501885, 501886, 501887, 501888, 501889, 501890, 501891, 501892, 501893, 501894, 501895, 501896, 501897, 510733, 510734, 510735, 510736, 510737, 510738, 510739, 510740, 510741, 510742, 510743, 510744, 510745, 510746, 510747, 510748, 510749, 510750, 510751, 510752, 510834, 510835, 510836, 510837, 510838, 510839, 510840
  • Product Classification
    Neurological Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US state of FL
  • Product Description
    Arthrex Shoulder Suspension Tower; Catalog Number: AR-1650-01 || Product Usage: || The Arthrex Lateral Decubitus Shoulder Positioner is intended to allow for the controlled manipulation of the arm and shoulder joint during arthroscopic surgical procedures.
  • Manufacturer
    Allen Medical Systems, Inc.

Manufacturer

Allen Medical Systems, Inc.
  • Manufacturer Address
    Allen Medical Systems, Inc., One Post Office Square, Acton MA 01720
  • Manufacturer Parent Company (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA