Date Initiated by Firm |
September 24, 2020 |
Date Posted |
October 27, 2020 |
Recall Status1 |
Completed |
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.
04-CANNDRILL-MDN 04-CANNTAP-40-MDN 04-CANNTAP-45-MDN 04-CANNTAP-55-MDN 04-CANNTAP-65-MDN 04-CANNTAP-75-MDN 04-CANNTAP-85-MDN 04-CTAP-TT-65-MDN 04-S-FINDER-MDN 05-SCREWINS-CL-MDN 05-SIMPDRIVER-MDN 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/ Manufacturer |
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) 375 River Park Cir Marquette MI 49855-1781
|
For Additional Information Contact |
Jeffrey Duncan 906-226-9909
|
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
|
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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.
|
510(K) Database |
510(K)s with Product Code = OLO and Original Applicant = Pioneer Surgical Technology, Inc. DBA RTI Surgical, Inc.
|