DePuy Spine Recalls Pipeline LS Holding Clips for Uncleared Use
DePuy Spine is recalling 198 Pipeline LS Holding Clips 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. The hazard involves the use of a device for an uncleared indication (neuromonitoring) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
DePuy Spine, Inc. is recalling 198 units of the Pipeline LS Access System Holding Clip. The recall is being conducted because the dilators and holding clips were used for a secondary function of neuromonitoring, for which the device is not 510(k) cleared.
The affected products were distributed nationwide, including to 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 items is 287105090.
Healthcare providers and patients should stop using the affected holding clips for neuromonitoring. The device is intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor, but it has not received FDA clearance for the specific neuromonitoring application cited in the recall.
The recalled product
- Product
- PIPELINE LS ACCESS SYSTEM, Holding Clip 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
- 198
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)
- 287105090
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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