Recall Z-0119-2027— Intellijoint Surgical, Inc.

Name: FDA recall Z-0119-2027
Creator: U.S. Food and Drug Administration
Published: 2026-08-28

Class II · Ongoing

Class II FDA medical device recall by Intellijoint Surgical, Inc., initiated 2026-08-28. It names one FDA 510(k) clearance: K191507. Product: Intellijoint Navigation System: Workstation G2 Configured, REF: 000-0241; Intellijoint HIP Cart System, REF: 000-0250; Intellijoint HIP, Portable System, REF: 000-0249. 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 MacBook Pro battery, subject to an Apple battery recall, that may overheat and pose a fire safety risk..

Recalling firm: Intellijoint Surgical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2026-08-28
Firm location: Kitchener, N/A, Canada

510(k) clearances named in this recall

1 on FDA's record

K191507 — Intellijoint® Navigation SystemIntellijoint Surgical, Inc.·cleared 2019-10-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.