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U.S. Department of Health and Human Services

Class 2 Device Recall RTI Surgical Streamline OCT OccipitoCervicoThoracic Spinal Rod

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  Class 2 Device Recall RTI Surgical Streamline OCT OccipitoCervicoThoracic Spinal Rod see related information
Date Initiated by Firm September 16, 2016
Date Posted October 20, 2016
Recall Status1 Terminated 3 on June 01, 2017
Recall Number Z-0290-2017
Recall Event ID 75242
510(K)Number K150254  
Product Classification Appliance, fixation, spinal interlaminal - Product Code KWP
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.
Code Information 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
Recalling Firm/
Manufacturer		 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
375 River Park Cir
Marquette MI 49855-1781
For Additional Information Contact Jennifer Mannor
906-225-5872
Manufacturer 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.
FDA Determined
Cause 2		 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 (dnelson@rtix.com) 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: jmannor@rtix.com 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,.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KWP and Original Applicant = Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.)
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