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U.S. Department of Health and Human Services

Class 2 Device Recall Intellijoint Navigation System

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 Class 2 Device Recall Intellijoint Navigation Systemsee related information
Date Initiated by FirmAugust 28, 2026
Date PostedOctober 07, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0119-2027
Recall Event ID 99821
510(K)NumberK191507 
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
ProductIntellijoint Navigation System: Workstation G2 Configured, REF: 000-0241; Intellijoint HIP Cart System, REF: 000-0250; Intellijoint HIP, Portable System, REF: 000-0249
Code Information REF/UDI-DI/MacBook Serial Numbers: 000-0241/00628184002414/C02RP36YG8WP, C02QPCF5G8WN 000-0250/00628184002506/C02RF44TG8WN, C02QW25RG8WL, C02QH355G8WM, C02S22N9G8WP; 000-0249/00628184002490/C02RQ3FUG8WN, C02R4451G8WN
FEI Number 3010822102
Recalling Firm/
Manufacturer		 Intellijoint Surgical, Inc.
809 Wellington St N Unit 2
Kitchener Canada
Manufacturer Reason
for Recall		A navigation system used to aid in selection and positioning of orthopedic implant system components has a workstation that may contain a 15-inch MacBook Pro battery, subject to an Apple battery recall, that may overheat and pose a fire safety risk.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn 8/28/2026, recall notices were emailed to customers who were asked to do the following: - If affected serial numbers are found, stop use and contact firm's customer service: at customerservice@intellijointsurgical.com and copy regulatory@intellijointsurgical.com - If the observed serial number does not match the affected serial number please record the serial number identified and inform customerservice@intellijointsurgical.com and cc regulatory@intellijointsurgical.com of the correct serial number for that facility.
Quantity in Commerce8
DistributionWorldwide - US Nationwide distribution in the states of CA, TX, MS, NJ and the countries of Singapore, Spain.
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
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