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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 Systemsee related information
Date Initiated by FirmSeptember 11, 2020
Create DateOctober 31, 2020
Recall Status1 Terminated 3 on May 23, 2024
Recall NumberZ-0320-2021
Recall Event ID 86591
510(K)NumberK200095 
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
ProductStreamline MIS Navigation System Taps, Catalog numbers 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
Code Information Lot numbers  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 ContactMr. Jeffrey Duncan
906-226-9909
Manufacturer Reason
for Recall		The Streamline MIS Navigation System taps are not compatible with the Streamline MIS tap sleeve.
FDA Determined
Cause 2		Device Design
ActionOn September 11, 2020, Pioneer Surgical sent out an advisory notice to their distributor (Surgalign) as a voluntary correction with no removal of devices from the field. However, after the advisory notice was distributed, a different issue related to the Streamline MIS Navigation taps becoming bound within Medtronic's Stealth Navigation System NavLock Tracker was reported. As a result, a second notification was sent out on September 24, 2020, changing the action to a voluntary recall. All instruments from the Streamline MIS Navigation System (as well as the Streamline TL Navigation System) were requested to be removed from the field. Please see RES 86559 for details on the September 24, 2020, recall. Customers are asked to do the following: -Remove all affected product from user sites and inventory locations -Return affected product to RTI Surgical, using RGA number - 63000897, along with a completed copy of the Acknowledgement and Receipt Form -Immediately notify any of your customers who have received the affected devices by providing them with a copy of the recall letter and response form for completion when returning affected devices.
Quantity in Commerce143 units
DistributionProduct distributed to Surgalign, a distributor located in Michigan.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = OLO
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