PIPELINE LS ACCESS SYSTEM, 15 Dilator, 5 mm, Insulated The PIPLINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.
FDA Recall Z-0093-2014 · Posted 2013-10-23
Recalling FirmDePuy Spine, Inc.
Recall StatusTerminated
Product CodeGCC
Date Initiated2013-07-31
Date Terminated2015-06-29
Product Quantity118 units
Reason for Recall
Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.
Firm Action
DePuy Synthes sent an Urgent Voluntary Product Recall Notification letter dated July 30, 2013, to all affected consignees via Fed Ex overnight delivery.
Consignees were informed that DePuy Spine, Inc. is voluntarily recalling all lots of the PIPELINE LS ACCESS SYSTEM Dilators (1 st, 2nd, 3rd, and 4th) and Holding Clip. They were asked to review inventory located at their facility and quarantine any products listed in this recall notice. Consignees were instructed to contact their local DePuy Synthes Spine Sales Consultant to return any inventory located within their facility.
Consignees with questions were instructed to call 508-828-3583.
Root Cause
Under Investigation by firm
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.