Device recall
Intellijoint Navigation System: Workstation G2 Configured, REF: 000-0241; Intellijoint HIP Cart System, REF: 000-0250; Intellijoint HIP, Portable System, REF: 000-0249
- Recall number
- Z-0119-2027
- Event id
- 99821
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Intellijoint Surgical, Inc.
- Report date
- Oct 14, 2026
- Posted
- Oct 7, 2026
- Initiated
- Aug 28, 2026
- Center classification date
- Oct 7, 2026
- Product code
- OLO
- Device type
- Orthopedic Stereotaxic Instrument
- 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.
- Root cause
- Nonconforming Material/Component
- Quantity
- 8
- 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
- Distribution
- Worldwide - US Nationwide distribution in the states of CA, TX, MS, NJ and the countries of Singapore, Spain.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K191507
- Location
- Kitchener, N/A, Canada