[Recalled] 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 skelet
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| 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 |
|---|---|
| Brand / manufacturer | PIONEER SURGICAL TECHNOLOGY, INC. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2616-2014 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 14 June 2013 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: The affected fixed rod holders did not allow the instrument to lock down on the spinal rod.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
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This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.