Intellijoint Navigation System: Workstation G2 Configured… recallZ-0119-2027 · Intellijoint Surgical, Inc. · initiated Aug 28, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Intellijoint Surgical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Nonconforming Material/Component
What the company is doing
On 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 [email protected] and copy [email protected] - If the observed serial number does not match the affected serial number please record the serial number identified and inform [email protected] and cc [email protected] of the correct serial number for that facility.
Recall details
- Recall number
- Z-0119-2027
- Status
- Open, Classified
- Initiated by the company
- Aug 28, 2026
- Posted by the FDA
- Oct 7, 2026
- Recalling firm
- Intellijoint Surgical, Inc.
- Quantity
- 8
- Product code
- OLO
- FDA submissions
- K191507
- Distribution
- Worldwide - US Nationwide distribution in the states of CA, TX, MS, NJ and the countries of Singapore, Spain.
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
Code information (models, lots, serial numbers)
REF/UDI-DI/MacBook Serial Numbers: 000-0241/00628184002414/C02RP36YG8WP, C02QPCF5G8WN 000-0250/00628184002506/C02RF44TG8WN, C02QW25RG8WL, C02QH355G8WM, C02S22N9G8WP; 000-0249/00628184002490/C02RQ3FUG8WN, C02R4451G8WN
Devices named in this recall
3 devices in the FDA device registry whose identifier appears in the recall's code information.
- intellijoint HIP® 000-0241Intellijoint Surgical Inc · Orthopedic Stereotaxic Instrument1 recall0 reports
- intellijoint HIP® 000-0249Intellijoint Surgical Inc · Orthopedic Stereotaxic Instrument1 recall0 reports
- intellijoint HIP® 000-0250Intellijoint Surgical Inc · Orthopedic Stereotaxic Instrument1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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