DePuy Spine Recalls Pipeline LS Dilators for Uncleared Neuromonitoring Use
DePuy Spine is recalling 100 units of Pipeline LS Dilators because they were used for neuromonitoring, a function for which the device is not FDA cleared.
What this means for you
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 injuries, illnesses, or hospitalizations. The hazard is the use of the device for an uncleared function, which fits the criteria for a moderate severity recall involving regulatory non-compliance without reported harm.
Plain-English summary
DePuy Spine, Inc. is recalling 100 units of the PIPELINE LS ACCESS SYSTEM, 4th Dilator, 18 mm, Insulated. The recall is due to the device being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. The product is intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.
The affected units were distributed nationwide, including in 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 specific code for the recalled units is 287105018.
Healthcare providers and consumers should stop using the affected dilators for neuromonitoring purposes. Users should contact DePuy Spine, Inc. for further instructions regarding the return or replacement of the devices.
The recalled product
- Product
- 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.
- Manufacturer
- DePuy Spine, Inc.
- Hazard
- Affected units
- 100
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)
- 287105018
Distribution
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.
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