FDAClass IIApril 20, 2016

RTI Surgical Streamline Occipito-Cervico-Thoracic recall

RTI Surgical Streamline Occipito-Cervico-Thoracic (OCT) Final Driver, Common Name: Screw Driver

Why was RTI Surgical Streamline Occipito-Cervico-Thoracic recalled?

Multiple lots of the 26-FNLDRIVER, may have reduced mechanical strength, resulting in driver tip fracturing during use.

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?

26-FNLDRIVER, Lot Numbers: 177091, 177093, 183817, 207727, 223926, 227291, 229134, 230523, 232262, 233074, 234205

Product
RTI Surgical Streamline Occipito-Cervico-Thoracic (OCT) Final Driver, Common Name: Screw Driver
Recalling firm
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Quantity
N/A
Distribution
Domestic: AL, CO, CT, FL, IN, ID, IL, MI, MS, MO, NC, NY, TX Foreign: None VA/DOD: None
Recall date
April 20, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls