Streamline OCT Occipito-Cervico-Thoracic System recallZ-0290-2017 · RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) · initiated Sep 16, 2016

Why it was recalled

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.

FDA root cause category: Process control

What the company is doing

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.

Recall details

Recall number

Z-0290-2017

Status

Terminated

Initiated by the company

Sep 16, 2016

Posted by the FDA

Oct 20, 2016

Recalling firm

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

Quantity

66

Product code

KWP

FDA submissions

K150254

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 description

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.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• STREAMLINE®* OCT OCCIPITO-CERVICO-THORACIC SYSTEM 23-CC-ROD-240

  Pioneer Surgical Technology, Inc. · APPLIANCE, FIXATION, SPINAL INTERLAMINAL
  1 recall0 reports

Product lines

• Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. · 4 models · 3 reports · 1 recall