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Terminated

Arthex S3 Arm Sleeve Connector; Catalog Number AR-1650-02; manufactured and distributed between March and November 2016.

FDA Recall Z-0928-2017 · Posted None

Recalling FirmAllen Medical Systems, Inc.
Recall StatusTerminated
Product CodeHST
Date Initiated2016-11-23
Date Terminated2019-08-20
Product Quantity420 devices

Reason for Recall

During use, the unit could separate un-expectantly. This failure would allow the patient's arm to fall out of suspension during a procedure, possibly causing moderate injury to the patient. This potential defect is not apparent to the user.

Firm Action

The firm's customer was notified of the recall via letter on November 23, 2016. They were asked to take the following actions: 1. Immediately remove from service your Arthrex S3 Arm Sleeve Connector (AR-1650-02). All serial numbers are impacted. 2. Please follow the included instructions for the return of all S3 Arm Sleeve Connectors (AR-1650-02). Allen Medical will inspect, repair or replace all units as necessary at no cost to you. Please take steps to retrieve the units from your customers and return them to Allen Medical via the standard Return Material Authorization (RMA) process. In order to minimize this inconvenience, we will repair the Arthrex S3 Arm Sleeve Connector and return the device to you as soon as possible. For further questions, please call (978) 266-4280.

Root Cause

Under Investigation by firm

Distribution Pattern

US Distribution to the 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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