PIPELINE LS ACCESS SYSTEM — Class II medical device recall Z-0097-2014
Terminated recall by DePuy Spine, Inc., reported 2013-11-06, distributed nationwide. Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(
| Recall number | Z-0097-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DePuy Spine, Inc., Raynham, MA, United States |
| Recall initiated | 2013-07-31 |
| Classified | 2013-10-28 |
| Reported by FDA | 2013-11-06 |
| Terminated | 2015-06-29 |
| Distributed | Nationwide (US) |
| Quantity | 198 units |
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.
Reason for recall
Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0097-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.