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DePuy Spine, Inc. recalls PIPELINE LS ACCESS SYSTEM, Holding Clip The PIPELINE LS Dilators and Holding Clip are intended for sequential dilatio
Recalled November 6, 2013 · FDA recall Z-0097-2014 · DePuy Spine
Hazard
Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. · FDA Class II
Units
198 units
Sold at
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.
Description
Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.
Product
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.
Manufacturer(s)
DePuy Spine, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →