Recall Z-0096-2014— DePuy Spine, Inc.
Class II · Terminated
Class II FDA medical device recall by DePuy Spine, Inc., initiated 2013-07-31, terminated 2015-06-29. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared..
- Recalling firm
- DePuy Spine, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-07-31
- Terminated
- 2015-06-29
- Firm location
- Raynham, MA, United States
Product description
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.
Reason for recall
Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.
Data sourced from openFDA. This site is unofficial and independent of the FDA.