Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall CORI REAL INTELLIGENCE Robotic Drill

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall CORI REAL INTELLIGENCE Robotic Drillsee related information
Date Initiated by FirmNovember 13, 2023
Date PostedJanuary 11, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0708-2024
Recall Event ID 93620
510(K)NumberK231963 
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
ProductCORI REAL INTELLIGENCE Robotic Drill, Product No. ROB10013 and ROB10013S
Code Information UDI-DI: 00885556757321 and 00885556780886; Serial No. SN00001 through SN001202, SN500001 through SN502583.
FEI Number 3016090213
Recalling Firm/
Manufacturer		 Blue Belt Technologies, Inc
2875 Railroad St
Pittsburgh PA 15201
Manufacturer Reason
for Recall		Possibility that the user is unable to resolve drill disconnection error messages.
FDA Determined
Cause 2		Device Design
ActionThe recalling firm sent an Urgent Medical Device Recall/Correction notice, dated 11/13/23, by mail to consignees. The notice informed consignees that they may continue to use affected devices as is provided that they ensure the backup Robotics Instrument Tray is available during surgery and to review the CORI Surgical System User Manual, which provides instructions for solving error messages. If consignees are unable to resolve the error messages, they should be prepared to convert to manual surgical procedure following the instructions in Appendix D: Recovery Procedure Guidelines of the CORI Surgical System User Manual. In accordance with routine servicing, consignees should return the CORI drill after 75 uses for servicing, during which the recalling firm will make the hardware update required to correct this recall event. Consignees are asked to contact their Account Representative to report pervasive drill disconnection error messages. Completed acknowledgement forms are to be returned to the recalling firm by email at fieldactions@Smith-Nephew.com. Questions are to be directed by email to fieldactions@smith-nephew.com or to your Account Representative.
Quantity in Commerce1859 units
DistributionDomestic: Nationwide Distribution.
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 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) Database510(K)s with Product Code = OLO
-
-