FDAClass IISeptember 17, 2014

Streamline MIS Spinal Fixation System Fixed Rod Holder recall

Streamline MIS Spinal Fixation System Fixed Rod Holder NON STERILE, Rx only The Streamline MIS Spinal Fixation System is intended for posterior…

Why was Streamline MIS Spinal Fixation System Fixed Rod Holder recalled?

The affected fixed rod holders did not allow the instrument to lock down on the spinal rod.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot number: 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…
Recalling firm
PIONEER SURGICAL TECHNOLOGY, INC.
Quantity
9
Distribution
Nationwide Distribution including TX, CA, IL, and FL.
Recall date
September 17, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls