Allen Medical Systems, Inc. recalls Arthrex Shoulder Suspension Tower; Catalog Number: AR-1650-01 Product Usage: The Arthrex Lateral Decubitus Shoulder Pos…

Recall date

January 3, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1198-2017

FDA classification

Class II

Brand / firm

Allen Medical Systems, Inc.

Sold / distributed

US state of FL

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.