Drug recall
Streamline MIS Spinal Fixation System Fixed Rod Holder NON STERILE, Rx only The Streamline MIS Spinal Fixation…
FDA recall event 69036 · Class II · PIONEER SURGICAL TECHNOLOGY, INC.
Key facts
| Event ID | 69036 |
|---|---|
| Recall numbers | Z-2616-2014 |
| Recalling firm | PIONEER SURGICAL TECHNOLOGY, INC. |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The affected fixed rod holders did not allow the instrument to lock down on the spinal rod. |
| Initiation date | Jun 14, 2013 |
| Report date | Sep 17, 2014 |
| Termination date | Sep 30, 2014 |
| City | Marquette |
| State | MI |
| Country | United States |
| FEI number | 1000115331 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: