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
501798501799501800501801501802501803501804501805501806501807501808501809501810501811501812501813501814501815501816501817501818501819501820501821501822501823501824501825501826501827501828501829501830501831501832501833501834501835501836501837501838501839501840501841501842501848501849501850501851501852501853501854501855501856501857501863501864501865501866501867
- Serial Numbers
- 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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