Z-0097-2014 Class II Terminated
FDA device recall Z-0097-2014 was initiated by DePuy Spine, Inc. on Jul 31, 2013 and is designated Class II. Reason for recall: Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. The recall status is terminated (terminated Jun 29, 2015). Affected quantity: 198 units.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 6, 2013
- Initiation Date
- Jul 31, 2013
- Termination Date
- Jun 29, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 198 units
Product Description
PIPELINE LS ACCESS SYSTEM, Holding Clip The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.
Reason for Recall
Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.
Distribution Pattern
Nationwide Distribution including the states of AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, WV, and WY.
Code Information
287105090