PIPELINE LS ACCESS SYSTEM, 4th Dilator, 18 mm, Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequ

FDA device recall Z-0096-2014 · posted 2013-10-23 · Terminated

Recall details

Recalling firm

DePuy Spine, Inc.

Reason for recall

Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.

Action taken

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

Status

Terminated

Product code

GCC

Quantity affected

100 units

Distribution

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,

Date initiated

2013-07-31

Date posted

2013-10-23

Date terminated

2015-06-29

Location

Raynham, MA