DePuy Spine, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0096-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

PIPELINE LS ACCESS SYSTEM, 4th Dilator, 18 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.

Product Classification:

Class II

Date Initiated: July 31, 2013

Date Posted: November 6, 2013

Recall Number: Z-0096-2014

Event ID: 65897

Reason for Recall:

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

Status: Terminated

Product Quantity: 100 units

Code Information:

287105018

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.

Voluntary or Mandated:

Voluntary: Firm initiated