Device product
Spine Wave Access Kit, Catalog Number 10-1530 Package contents: RLSP494-Rhythmlink Monopolar Stimulating Probe and 10-1525 Disposable Dilator Set. Product Usage: The Spine Wave Access Kit is comprised of a sterile monopolar stimulating probe (individually packaged by Rhythmlink International) and a set of three sterile disposable dilators (individually packaged by Spine Wave). The Rhythmlink International Monopolar Stimulating Instrument is indicated for stimulation of cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots.
Z-1960-2015
Product summary
- Firm
- Spine Wave, Inc.
- Event
- Event 71497
- Status
- Terminated
- Classification
- Class II
- Quantity
- 121 units
- Official record key
device-enforcement:Z-1960-2015
Official wording
Reason: Mislabeled outer carton: Monopolar Probe is listed as 200 x 1.5mm when it should be listed as 280 x 1.5mm
Code information: Lot Codes: 092514Z, 120814A, 011415H and 022415F
Distribution pattern: US Nationwide Distribution in the state of CA, FL, GA, LA, MA, MD, MI, MO, NC, NH, OH, OR, PA, TX, and VA.
Derived failure modes
-
Labeling or packaging
Mislabeled