Z-1542-2012

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

Name: Z-1542-2012 Norco Shoulder Pulley Distributed by North Coast Medical, Gilroy, CA. Used to improve range of shoulder...
Creator: North Coast Medical Inc
Published: 2011-07-11
License: https://open.fda.gov/license/

North Coast Medical Inc / initiated 2011-07-11 / Terminated / root cause: design

FDA source

North Coast Medical Inc began a recall of Norco Shoulder Pulley Distributed by North Coast Medical, Gilroy, CA. Used to improve range of shoulder movement and coordination following a stroke, shoulder... on 2011-07-11. The reason FDA records is "Potential for plastic D-ring to break during use and cause injury". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1542-2012
Status: Terminated
Initiated: 2011-07-11
Posted: 2012-05-14
Terminated: 2012-09-06
Recalling firm: North Coast Medical Inc
Product: 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.
Product code: ION Exerciser, Non-Measuring
Reason for recall: Potential for plastic D-ring to break during use and cause injury.
Root cause tag: design
FDA 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 in commerce: 2364 units
Distribution: Worldwide Distribution-USA (nationwide) and the countries of Australia, Canada, Switzerland, Germany, Great Britain and the Netherlands.
Product codes and lots: Product number NC52069. Product does not have lot/serial numbers, expiration dates or UPC numbers.

Product code ION

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)