Recall Z-1542-2012 ยท ION Exerciser, Non-Measuring
North Coast Medical Inc
Norco Shoulder Pulley Distributed by North Coast Medical, Gilroy, CA. Used to improve range of shoulder movement and coordination following a stroke, shoulder injury or surgery.
| Date | May 14, 2012 (initiated Jul 11, 2011) |
| Status | Terminated |
| Reason | Potential for plastic D-ring to break during use and cause injury. |
| Root cause | Device Design |
| Action | North Coast Medical began contacting customers of the recall on July 13, 2011 by telephone. A phone script was used to inform customers of the affected product, problem, and actions to be taken by the customers. Information was provided for customers to return affected product. Affected devices were re-worked and inspected. Contact the firm by e-mail at www.ncmedical.com for questions regarding this recall. |
| Quantity | 2364 units |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Australia, Canada, Switzerland, Germany, Great Britain and the Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.