Spine Wave Access Kit, Catalog Number 10-1530 Package contents: RLSP494-Rhythmlink Monopolar Stimulating Probe and 10-15
FDA device recall Z-1960-2015 · posted 2015-07-02 · Terminated
Recall details
- Recalling firm
- Spine Wave, Inc.
- Reason for recall
- Mislabeled outer carton: Monopolar Probe is listed as 200 x 1.5mm when it should be listed as 280 x 1.5mm
- Action taken
- Spine Wave sent an Urgent: Medical Device Recall letter dated June 11, 2015 to affected customers. The letter identified the affect product, problem and actions to be taken. Customers were instructed to acknowledge receipt of notification by returning the enclosed Recall Notice Acknowledgement Form in the stamped envelope provided. For questions, contact Spine Wave directly at 203-944-9494 and ask for the Recall Coordinator or by email at rsmith@spinewave.com.
- Root cause
- Packaging change control
- Status
- Terminated
- Product code
- ETN
- Quantity affected
- 121 units
- Distribution
- US Nationwide Distribution in the state of CA, FL, GA, LA, MA, MD, MI, MO, NC, NH, OH, OR, PA, TX, and VA.
- Date initiated
- 2015-05-04
- Date posted
- 2015-07-02
- Date terminated
- 2017-01-24
- Location
- Shelton, CT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RHYTHMLINK INTERNATIONAL MONOPOLAR STIMULATING INSTRUMENT (K072736) | Rhythmlink International, LLC | 2008-01-22 |