Recall Z-0119-2027 · OLO Orthopedic Stereotaxic Instrument
Intellijoint Surgical, Inc.
Intellijoint Navigation System: Workstation G2 Configured, REF: 000-0241; Intellijoint HIP Cart System, REF: 000-0250; Intellijoint HIP, Portable System, REF: 000-0249
| Date | Oct 7, 2026 (initiated Aug 28, 2026) |
| Status | Open, Classified |
| 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 |
| 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 customerservice@intellijointsurgical.com and copy regulatory@intellijointsurgical.com - If the observed serial number does not match the affected serial number please record the serial number identified and inform customerservice@intellijointsurgical.com and cc regulatory@intellijointsurgical.com of the correct serial number for that facility. |
| Quantity | 8 |
| Distribution | Worldwide - US Nationwide distribution in the states of CA, TX, MS, NJ and the countries of Singapore, Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K191507 | Intellijoint® Navigation System Intellijoint Surgical, Inc., Oct 1, 2019 |