Norco Shoulder Pulley Distributed by North Coast Medical, Gilroy, CA. Used to improve range of shoulder movement and coo

FDA device recall Z-1542-2012 · posted 2012-05-14 · Terminated

Recall details

Recalling firm

North Coast Medical Inc

Reason for recall

Potential for plastic D-ring to break during use and cause injury.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

ION

Quantity affected

2364 units

Distribution

Worldwide Distribution-USA (nationwide) and the countries of Australia, Canada, Switzerland, Germany, Great Britain and the Netherlands.

Date initiated

2011-07-11

Date posted

2012-05-14

Date terminated

2012-09-06

Location

Gilroy, CA