Z-0119-2027

Intellijoint Navigation System: Workstation G2 Configured, REF: 000-0241; Intellijoint HIP Cart System, REF...

Name: Z-0119-2027 Intellijoint Navigation System: Workstation G2 Configured, REF: 000-0241; Intellijoint HIP Cart System, REF...
Creator: Intellijoint Surgical, Inc.
Published: 2026-08-28
License: https://open.fda.gov/license/

Intellijoint Surgical, Inc. / initiated 2026-08-28 / Open, Classified

FDA source

Recall record

Recall number: Z-0119-2027
Status: Open, Classified
Initiated: 2026-08-28
Posted: 2026-10-07
Recalling firm: Intellijoint Surgical, Inc.
Product: Intellijoint Navigation System: Workstation G2 Configured, REF: 000-0241; Intellijoint HIP Cart System, REF: 000-0250; Intellijoint HIP, Portable System, REF: 000-0249
Product code: OLO Orthopedic Stereotaxic Instrument
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 root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 8
Distribution: Worldwide - US Nationwide distribution in the states of CA, TX, MS, NJ and the countries of Singapore, Spain.
Product codes and lots: REF/UDI-DI/MacBook Serial Numbers: 000-0241/00628184002414/C02RP36YG8WP, C02QPCF5G8WN 000-0250/00628184002506/C02RF44TG8WN, C02QW25RG8WL, C02QH355G8WM, C02S22N9G8WP; 000-0249/00628184002490/C02RQ3FUG8WN, C02R4451G8WN

Product code OLO

K191507Class IIIntellijoint® Navigation SystemIntellijoint Surgical, Inc. / cleared 2019-10-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-10-09. View this recall on fda.gov (opens on fda.gov)