Z-1393-2016Class II

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

Name: Z-1393-2016 RTI Surgical Streamline Occipito-Cervico-Thoracic (OCT) Final Driver, Common Name: Screw Driver
Creator: RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Published: 2016-03-18
License: https://open.fda.gov/license/

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) / initiated 2016-03-18 / Terminated / root cause: manufacturing process

FDA source

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) began a recall of RTI Surgical Streamline Occipito-Cervico-Thoracic (OCT) Final Driver, Common Name: Screw Driver on 2016-03-18. FDA classified it as Class II and gives the reason as "Multiple lots of the 26-FNLDRIVER, may have reduced mechanical strength, resulting in driver tip fracturing during use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1393-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-18
Posted: 2018-10-11
Terminated: 2016-09-12
Recalling firm: RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Product: RTI Surgical Streamline Occipito-Cervico-Thoracic (OCT) Final Driver, Common Name: Screw Driver
Product code: KWP Appliance, Fixation, Spinal Interlaminal
Reason for recall: Multiple lots of the 26-FNLDRIVER, may have reduced mechanical strength, resulting in driver tip fracturing during use.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: RTI Surgical Inc. initiated a voluntary recall of RTI Surgical Streamline OCT Occipito-Cervico-Thoracic Final Driver, via written notices sent by e-mail and FedEx on 03/18/2016. Customers are requested to review all inventory, quarantine products listed in the recall, and to immediately return recalled products with the recall reply form, and the shipping labels and authorization numbers provided within 5 days of receiving notice. Replacement drivers are being sent to customers. Customers may contact Dan Nelson, Manager of Quality Systems, Phone: 906-226-4489, Fax: 906-226-4455, e-mail: [email protected].
Distribution: Domestic: AL, CO, CT, FL, IN, ID, IL, MI, MS, MO, NC, NY, TX Foreign: None VA/DOD: None
Product codes and lots: 26-FNLDRIVER, Lot Numbers: 177091, 177093, 183817, 207727, 223926, 227291, 229134, 230523, 232262, 233074, 234205

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1393-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1393-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14

Product code KWP

K150254Class IIStreamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) / cleared 2015-04-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)