Recall Z-0928-2017 ยท HST Apparatus, Traction, Non-Powered
Allen Medical Systems, Inc.
Arthex S3 Arm Sleeve Connector; Catalog Number AR-1650-02; manufactured and distributed between March and November 2016.
| Date | Nov 23, 2016 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Under Investigation by 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 or |
| Quantity | 420 devices |
| Distribution | US Distribution to the state of : FL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.