FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1542-2012
- 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.
- Status
- Terminated
- Initiated
- 2011-07-11
- Posted
- 2012-05-14
- Terminated
- 2012-09-06
- 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.
- Lot, serial or model codes
- Product number NC52069. Product does not have lot/serial numbers, expiration dates or UPC numbers.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- ION
- Firm FEI
- 1000124207
- Firm city
- Gilroy
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28