Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0093-2014·Announced 2013-11-06

DePuy Spine Pipeline LS Dilator Recall for Uncleared Neuromonitoring Use

DePuy Spine is recalling 118 Pipeline LS Dilators and Holding Clips because they were used for neuromonitoring, a function for which the devices are not FDA cleared.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses or injuries, and the hazard is related to an uncleared secondary use rather than a direct defect causing harm.

Plain-English summary

DePuy Spine, Inc. is recalling 118 units of the Pipeline LS Access System, 15 Dilator, 5 mm, Insulated, and Holding Clip. The recall is due to the devices being used for a secondary function of neuromonitoring, for which they are not 510(k) cleared by the FDA.

The affected products are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor. The recall covers 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.

The source text does not specify specific actions for consumers or healthcare providers, nor does it report any illnesses or injuries associated with this recall.

The recalled product

Product: 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.
Manufacturer: DePuy Spine, Inc.
Category: Medical Device — Surgical Instruments
Hazard: uncleared-use
Affected units: 118

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

287105005

Distribution

Distributed nationwide across the United States.

The notice also names 41 states specifically:

Part of a larger recall action

This product is one of 5 recalled by DePuy Spine, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Same manufacturer · DePuy Spine, Inc.

See all →

Moderate
EIT CIF Cage Intervertebral Fusion Device Carton Labeling Mismatch Recall
FDA (Devices) · 2022-07-13
Moderate
Intervertebral fusion device recalled for outer carton labeling discrepancy
FDA (Devices) · 2022-07-13
Severe
DePuy Spine Recalls Concorde Lift Spinal Fusion Implants Due to Migration
FDA (Devices) · 2019-05-08
High
DePuy Spine Recalls Concorde Lift Spinal Fusion Implants
FDA (Devices) · 2019-05-08
High
DePuy Spine Recalls Confidence Plus Kit Spinal Cement System Lots
FDA (Devices) · 2018-04-11

Same hazard · uncleared use