Reported Feb 22, 2017 · Terminated

Arthrex Shoulder Suspension Tower; Catalog Number: AR-1650-01 Product Usage: The Arthrex Lateral Decubitus Shoulder…

Allen Medical Systems, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Allen Medical Systems, Inc. · One Post Office Square · Acton, MA · 01720

Is this the product you have?

  • Arthrex Shoulder Suspension Tower
  • Catalog NumberAR-1650-01
  • Product UsageThe Arthrex Lateral Decubitus Shoulder Positioner is intended to allow for the controlled manipulation of the arm and shoulder joint during arthroscopic surgical procedures
Lot codes and dates
  • Serial Numbers

    112 of 112 codes

    • 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
Amount recalled
112 devices

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Oct 3, 2018 · Data as of Sep 19, 6:07 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.