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Open, Classified

Intellijoint Navigation System: Workstation G2 Configured, REF: 000-0241; Intellijoint HIP Cart System, REF: 000-0250; Intellijoint HIP, Portable System, REF: 000-0249

FDA Recall Z-0119-2027 · Posted 2026-10-07

Recalling FirmIntellijoint Surgical, Inc.
Recall StatusOpen, Classified
Product CodeOLO
Date Initiated2026-08-28
Product Quantity8

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide - US Nationwide distribution in the states of CA, TX, MS, NJ and the countries of Singapore, Spain.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K191507Intellijoint® Navigation SystemIntellijoint Surgical, Inc. · 2019-10-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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