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U.S. Department of Health and Human Services

Class 2 Device Recall Streamline OCT OccipitoCervicoThoracic System, Crosslink Counter Torque Sleeve

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  Class 2 Device Recall Streamline OCT OccipitoCervicoThoracic System, Crosslink Counter Torque Sleeve see related information
Date Initiated by Firm April 22, 2016
Date Posted May 26, 2016
Recall Status1 Terminated 3 on February 08, 2017
Recall Number Z-1829-2016
Recall Event ID 74031
510(K)Number K150254  
Product Classification Appliance, fixation, spinal interlaminal - Product Code KWP
Product Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve. Spinal fixation device instrument.
Code Information Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve; Lot Number: 170684; Part Number: 26-COUNTER-T-XLINK
Recalling Firm/
Manufacturer		 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
375 River Park Cir
Marquette MI 49855-1781
For Additional Information Contact Dan Nelson
906-226-4489
Manufacturer Reason
for Recall		 Potential for a product defect where the cannula may be obstructed. This obstruction could prevent a driver from going through, which increases the potential for the driver to slip, resulting in possible patient injury.
FDA Determined
Cause 2		 Process design
Action RTI sent an Urgent Voluntary Product Notification dated April 22, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. RTI Surgical is conducting a voluntary recall of the Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve due to the potential for a product defect where the cannula may be obstructed. This obstruction could prevent a driver from going through, which increases the potential for the driver to slip resulting in possible patient injury. For further questions, please call (906) 226-4489.
Quantity in Commerce 17 devices
Distribution US nationwide distribution in CA, FL, IN, MI, MO, NC, NY, and TX.
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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