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U.S. Department of Health and Human Services

Class 2 Device Recall Norco Shoulder Pulley

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 Class 2 Device Recall Norco Shoulder Pulleysee related information
Date Initiated by FirmJuly 11, 2011
Date PostedMay 14, 2012
Recall Status1 Terminated 3 on September 06, 2012
Recall NumberZ-1542-2012
Recall Event ID 61475
Product Classification Exerciser, non-measuring - Product Code ION
ProductNorco 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.
Code Information Product number NC52069. Product does not have lot/serial numbers, expiration dates or UPC numbers.
Recalling Firm/
Manufacturer		 North Coast Medical Inc
8100 Camino Arroyo
Gilroy CA 95020-7304
For Additional Information ContactCheri Koehler
800-821-9319 Ext. 121
Manufacturer Reason
for Recall		Potential for plastic D-ring to break during use and cause injury.
FDA Determined
Cause 2		Device Design
ActionNorth 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 in Commerce2364 units
DistributionWorldwide Distribution-USA (nationwide) and the countries of Australia, Canada, Switzerland, Germany, Great Britain and the Netherlands.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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