Date Initiated by Firm |
September 24, 2020 |
Date Posted |
October 27, 2020 |
Recall Status1 |
Completed |
Recall Number |
Z-0300-2021 |
Recall Event ID |
86559 |
510(K)Number |
K200095
|
Product Classification |
Orthopedic stereotaxic instrument - Product Code OLO
|
Product |
Streamline TL Navigation System, Catalog Nos.
02-C-TAP-55-MDN 02-C-TAP-60-L-MDN 02-C-TAP-65-L-MDN 02-C-TAP-65-MDN 02-C-TAP-75-L-MDN 02-C-TAP-85-L-MDN 02-C-TAP-85-MDN 02-C-TAP-95-L-MDN 02-RS-INS-C-MDN 02-RS-INSERTER-MDN 02-SCREWINS-CL-MDN 02-SCREWINS-C-MDN 02-S-FINDER-L-MDN 02-SFINDER-MDN 02-S-FINDER-T-MDN 02-TAP-45-MDN 02-TAP-55-MDN 02-TAP-60-L-MDN 02-TAP-65-L-MDN 02-TAP-65-MDN 02-TAP-75-L-MDN 02-TAP-75-MDN 02-TAP-85-L-MDN 02-TAP-85-MDN 02-TAP-95-L-MDN 02-MODHANDLE-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 372816 377619 372817 372813 372927 373852 377616 377620 372926 372925 372923 372924 366798 367040 366799 370212 371729 377621 371730 373437 371731 372815 377622 373845 377623 369372 370853 377624 |
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 |
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.
|