Recall Z-1198-2017 ยท HST Apparatus, Traction, Non-Powered
Allen Medical Systems, Inc.
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.
| Date | Feb 14, 2017 (initiated Jan 3, 2017) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| 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. |
| Quantity | 112 devices |
| Distribution | US state of FL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.