Recall Z-0095-2014 ยท GCC Dilator, Catheter
DePuy Spine, Inc.
PIPELINE LS ACCESS SYSTEM, 3rd Dilator, 14 mm Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.
| Date | Oct 23, 2013 (initiated Jul 31, 2013) |
| Status | Terminated |
| Reason | Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. |
| Root cause | Under Investigation by 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 q |
| Quantity | 102 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, WI, WV, and WY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.