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U.S. Department of Health and Human Services

Class 2 Device Recall Streamline MIS Navigation System

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  Class 2 Device Recall Streamline MIS Navigation System see related information
Date Initiated by Firm September 24, 2020
Date Posted October 27, 2020
Recall Status1 Open3, Classified
Recall Number Z-0299-2021
Recall Event ID 86559
510(K)Number K200095  
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
Product Streamline MIS Navigation System Taps, Catalog Nos.

Product Usage: intended to be used during the preparation and placement of screws from the Streamline TL and MIS Systems and preparation of screws from the Streamline OCT System during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures.
Code Information Lots 377520  371734 374791 374792 373438 371735 371736 377625 377806 371737 372819 371266 371733 
Recalling Firm/
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
375 River Park Cir
Marquette MI 49855-1781
For Additional Information Contact Jeffrey Duncan
Manufacturer Reason
for Recall
The Streamline Navigation System taps have experienced binding with other devices.
FDA Determined
Cause 2
Device Design
Action On September 24, 2020, the firm distributed the Urgent Medical Devices Recall letter to customers. Customers were instructed to remove affected product from all user sites and inventory locations. These instrument systems are to be returned to RTI Surgical along with a completed copy of the response form. Accounts who have further distributed the affected products are also asked to immediately notify their customers by providing them a copy of the recall letter and the response form for completion when returning the affected devices to RTI Surgical.
Quantity in Commerce 420 units
Distribution US Nationwide distribution including in the state of Michigan.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = OLO and Original Applicant = Pioneer Surgical Technology, Inc. DBA RTI Surgical, Inc.