FDA Device recall Z-2616-2014
Streamline MIS Spinal Fixation System Fixed Rod Holder NON STERILE, Rx only The Streamline MIS Spinal Fixation System is intended for poste…
- FDA Device
- Class II
- terminated
- Published 2014-09-17
On 2014-09-17 the FDA classified a Class II recall of Streamline MIS Spinal Fixation System Fixed Rod Holder NON STERILE, Rx only The Streamline MIS Spinal Fixation System is intended for poste… by Pioneer Surgical Technology, citing the affected fixed rod holders did not allow the instrument to lock down on the spinal rod.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2616-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-06-14 |
| Published | 2014-09-17 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Pioneer Surgical Technology |
| Distribution | US |
Product
Streamline MIS Spinal Fixation System Fixed Rod Holder NON STERILE, Rx only The Streamline MIS Spinal Fixation System is intended for posterior, noncervical pedicle fixation, T1-S2. Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion. The device is indicated for all the following indications: degenerative disc disease (ODD) (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, kyphosis, and /or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The Streamline MIS instrumentation, when used with the Streamline MIS Spinal Fixation System, is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.
Reason
The affected fixed rod holders did not allow the instrument to lock down on the spinal rod.
Identifiers
| code_info | Lot number: 148062, 148440 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2616-2014%22
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