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Terminated

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.

FDA Recall Z-1198-2017 · Posted 2017-02-14

Recalling FirmAllen Medical Systems, Inc.
Recall StatusTerminated
Product CodeHST
Date Initiated2017-01-03
Date Terminated2018-10-03
Product Quantity112 devices

Reason for Recall

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

US state of FL

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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