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Terminated

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.

FDA Recall Z-1542-2012 · Posted 2012-05-14

Recalling FirmNorth Coast Medical Inc
Recall StatusTerminated
Product CodeION
Date Initiated2011-07-11
Date Terminated2012-09-06
Product Quantity2364 units

Reason for Recall

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

Firm 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.

Root Cause

Device Design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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