Z-1960-2015 Class II Terminated
FDA device recall Z-1960-2015 was initiated by Spine Wave, Inc. on May 4, 2015 and is designated Class II. 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 The recall status is terminated (terminated January 24, 2017). Affected quantity: 121 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 8, 2015
- Initiation Date
- May 4, 2015
- Termination Date
- January 24, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 121 units
Product Description
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.
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
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.
Code Information
Lot Codes: 092514Z, 120814A, 011415H and 022415F