The Recall Desk

FDA (Devices) recall action 65897

DePuy Spine, Inc. recalled 5 products on 2013-11-06

The FDA (Devices) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.

Products
5
Announced
2013-11-06
Critical
0
Units
623

Why these products were recalled

Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–5 of 5

  • ModerateFDA (Devices)··2013-11-06

    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.

    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.
    Category
    Distribution
    41 states
  • ModerateFDA (Devices)··2013-11-06

    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.

    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.
    Category
    Distribution
    41 states
  • ModerateFDA (Devices)··2013-11-06

    DePuy Spine Recalls Pipeline LS Dilators for Uncleared Neuromonitoring Use

    DePuy Spine is recalling 105 Pipeline LS Access System dilators and holding clips because they were used for neuromonitoring, a function for which the devices are not cleared.

    Product
    PIPELINE LS ACCESS SYSTEM, 2nd Dilator, 10 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.
    Category
    Distribution
    41 states
  • HighFDA (Devices)··2013-11-06

    DePuy Spine Recalls Pipeline LS Dilators for Uncleared Neuromonitoring Use

    DePuy Spine is recalling 102 units of Pipeline LS Dilators and Holding Clips because they were used for neuromonitoring, a function for which the devices are not FDA cleared.

    Product
    PIPELINE LS ACCESS SYSTEM, 3rd Dilator, 14 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.
    Category
    Distribution
    41 states
  • ModerateFDA (Devices)··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.

    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.
    Category
    Distribution
    41 states