Intellijoint Navigation System: Workstation G2 Configured, REF: 000-0241; Intellijoint HIP Cart System, REF: 000-0250; I
Summary
The FDA issued a Class II for Intellijoint Navigation System: Workstation G2 Configured, REF: 000-0241; Intell by Intellijoint Surgical, Inc.. Reason: A navigation system used to aid in selection and positioning of orthopedic implant system components has a workstation that may contain a 15-inch MacB.
Details
Source
Device Recall
External ID
Z-0119-2027
Action Date
2026-10-14
Status
Ongoing
Category
device
Product Description
Intellijoint Navigation System: Workstation G2 Configured, REF: 000-0241; Intellijoint HIP Cart System, REF: 000-0250; Intellijoint HIP, Portable System, REF: 000-0249
Lot/Code Info: REF/UDI-DI/MacBook Serial Numbers: 000-0241/00628184002414/C02RP36YG8WP, C02QPCF5G8WN 000-0250/00628184002506/C02RF44TG8WN, C02QW25RG8WL, C02QH355G8WM, C02S22N9G8WP; 000-0249/00628184002490/C02RQ3FUG8WN, C02R4451G8WN
Quantity Affected: 8
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.
Distribution
Worldwide - US Nationwide distribution in the states of CA, TX, MS, NJ and the countries of Singapore, Spain.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-28
Company
Kitchener, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 220 device recalls issued in the same week, part of 502 device-related FDA actions this month.
Intellijoint Surgical, Inc. has 2 FDA actions in our database, including 1 recall and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Intellijoint Surgical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Intellijoint Surgical, Inc. have FDA actions?
Intellijoint Surgical, Inc. has 2 FDA actions in our database, including 1 recall and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0119-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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