Streamline MIS Spinal Fixation System Fixed Rod Holder NON STERILE — Class II medical device recall Z-2616-2014
Terminated recall by PIONEER SURGICAL TECHNOLOGY, INC., reported 2014-09-17, distributed nationwide. The affected fixed rod holders did not allow the instrument to lock down on the spinal rod.
| Recall number | Z-2616-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | PIONEER SURGICAL TECHNOLOGY, INC., Marquette, MI, United States |
| Recall initiated | 2013-06-14 |
| Classified | 2014-09-09 |
| Reported by FDA | 2014-09-17 |
| Terminated | 2014-09-30 |
| Distributed | Nationwide (US) |
| Quantity | 9 |
| Lot numbers | 148062, 148440 |
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 for recall
The affected fixed rod holders did not allow the instrument to lock down on the spinal rod.
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-2616-2014. 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.