Class II — PIONEER SURGICAL TECHNOLOGY, INC.
| Recalling firm | Pioneer Surgical Technology, Inc. |
|---|---|
| Registered facility | Pioneer Surgical Technology, Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The affected fixed rod holders did not allow the instrument to lock down on the spinal rod. |
| 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 curvat… |
| Quantity | 9 |
| Distribution | Nationwide Distribution including TX, CA, IL, and FL. |
| Initiated | 2013-06-14 |
| Classified | 2014-09-09 |
| Terminated | 2014-09-30 |
| Recall number | Z-2616-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — PIONEER SURGICAL TECHNOLOGY, INC. (Z-2616-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/69036/
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