Pioneer Surgical Technology Recalls Streamline MIS Spinal Fixation System Fixed Rod Holders
Pioneer Surgical Technology is recalling nine Streamline MIS Spinal Fixation System Fixed Rod Holders because they failed to lock onto the spinal rod.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the defect presents a risk of harm during surgery, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Pioneer Surgical Technology, Inc. is recalling nine units of the Streamline MIS Spinal Fixation System Fixed Rod Holder. The affected devices are non-sterile, prescription-only instruments intended for posterior, noncervical pedicle fixation in skeletally mature patients. The recall covers lot numbers 148062 and 148440.
The recall was initiated because the affected fixed rod holders did not allow the instrument to lock down on the spinal rod. This defect could prevent the proper use of the device during minimally invasive posterior spinal surgery.
The affected units were distributed nationwide, including in Texas, California, Illinois, and Florida. Healthcare facilities and patients who have received this device should contact Pioneer Surgical Technology for instructions on how to return or replace the product.
The recalled product
- 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…
- Manufacturer
- PIONEER SURGICAL TECHNOLOGY, INC.
- Hazard
- Affected units
- 9
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot number: 148062
- 148440
Distribution
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