Z-0290-2017Class II

RTI Surgical Streamline OCT Occipito-Cervico-Thoracic Spinal Rod, CoCr, 3.2mm (D) x 240mm (L)

Name: Z-0290-2017 RTI Surgical Streamline OCT Occipito-Cervico-Thoracic Spinal Rod, CoCr, 3.2mm (D) x 240mm (L)
Creator: RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Published: 2016-09-16
License: https://open.fda.gov/license/

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) / initiated 2016-09-16 / Terminated / root cause: manufacturing process

FDA source

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) began a recall of RTI Surgical Streamline OCT Occipito-Cervico-Thoracic Spinal Rod, CoCr, 3.2mm (D) x 240mm (L) Product Usage: When intended to promote fusion of the cervical... on 2016-09-16. FDA classified it as Class II and gives the reason as "RTI Surgical Inc. (RTI) is conducting a voluntary recall on two specific lots of the Streamline OCT Straight Rod, CoCr. 3.2mm (D) x 240mm (L) due to the potential for small cracks to be present on the rods. The small...". 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-0290-2017
Classification: Class II
Status: Terminated
Initiated: 2016-09-16
Posted: 2016-10-20
Terminated: 2017-06-01
Recalling firm: RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Product: RTI Surgical Streamline OCT Occipito-Cervico-Thoracic Spinal Rod, CoCr, 3.2mm (D) x 240mm (L) Product Usage: When intended to promote fusion of the cervical spine and occipitocervico-thoracic junction (occiput-T3), the Streamline OCT Occipito-Cervico-Thoracic System is intended for: degenerative disc disease (as defined by neck or back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture/ dislocation, atlanto/axial fracture with instability, occipito-cervical dislocation, deformities or curvature, tumors, pseudoarthrosis, and revision of previous cervical and upper thoracic spine surgery. The occipital bone screws are limited to occipital fixation only. The use of the pedicle screws (standard and high angle) is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. The pedicle screws are not intended for use in the cervical spine. The hooks, connectors, and rods are also intended to provide stabilization to promote fusion following reduction of fracture/ dislocation or trauma in the cervical/ upper thoracic (C1-T3) spine.
Product code: KWP Appliance, Fixation, Spinal Interlaminal
Reason for recall: RTI Surgical Inc. (RTI) is conducting a voluntary recall on two specific lots of the Streamline OCT Straight Rod, CoCr. 3.2mm (D) x 240mm (L) due to the potential for small cracks to be present on the rods. The small cracks on the rods used in implants could cause reduced strength of these affected implants, and lead to patient injury.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: RTI issued e-mail cutsomer notices for their voluntary recall of lots 234829 and 234829 of the Streamline OCT Straight Rod, CoCr, 3.2mm (D) x 240mm (L) on 09/16/2016. RTI Surgical has produced replacement implants that have been verified as not containing any cracks. These implants will be sent to customers once they have identified how many replacements are needed. Please follow the below instructions. 1. Review inventory located in your facility and any other point of use locations that you may be responsible for. Immediately quarantine any implants listed in this recall notice. Please refer to the pictures included in customer notices for the etch location of the lot numbers for these implants: 2. Contact the RTI Surgical Field Inventory representative Jennifer Mannor so that replacements can be sent and an RGA and return shipping labels can be created if needed. 3. Review, complete and return the attached recall reply form to Dan Nelson ([email protected]) in accordance with the directions on the business reply form within 5 business days of receipt of this notification. Should customers have any questions please do not hesitate to contact RTI Surgical Field Inventory representative Jennifer Mannor (Email: [email protected] Phone: 906-225-5872.
Quantity in commerce: 66
Distribution: US Nationwide Distribution in the states of: AL, CA, CO, FL, IN, IL, MI, MO, MS, NC, NY, OK, TN, TX, and VA,.
Product codes and lots: Part Number: 23-CC-ROD-240; Lot Number: 234829, UDI Number: (01)0084646802 7179( 10}234829; Lot Number: 246678, UDI Number: {01}00846468027179{10}246678

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0290-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0290-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-19

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)