Z-0094-2014Class II

PIPELINE LS ACCESS SYSTEM, 2nd Dilator, 10 mm, Insulated The PIPELINE LS Dilators and Holding Clip are...

Name: Z-0094-2014 PIPELINE LS ACCESS SYSTEM, 2nd Dilator, 10 mm, Insulated The PIPELINE LS Dilators and Holding Clip are...
Creator: DePuy Spine, Inc.
Published: 2013-07-31
License: https://open.fda.gov/license/

DePuy Spine, Inc. / initiated 2013-07-31 / Terminated

FDA source

DePuy Spine, Inc. began a recall of PIPELINE LS ACCESS SYSTEM, 2nd Dilator, 10 mm, Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and... on 2013-07-31. FDA classified it as Class II and gives the reason as "Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0094-2014
Classification: Class II
Status: Terminated
Initiated: 2013-07-31
Posted: 2013-10-23
Terminated: 2015-06-29
Recalling firm: DePuy Spine, Inc.
Product: PIPELINE LS ACCESS SYSTEM, 2nd Dilator, 10 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 code: GCC Dilator, Catheter
Reason for recall: Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.
FDA 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 questions were instructed to call 508-828-3583.
Quantity in commerce: 105 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.
Product codes and lots: 287105010

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0094-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0093-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-06	2013-10-28
Z-0094-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-06	2013-10-28
Z-0095-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-06	2013-10-28
Z-0096-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-06	2013-10-28
Z-0097-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-06	2013-10-28

Product code GCC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)