CLASS II ONGOING Device recall · Reported 14 Oct 2026 · FDA Enforcement Report
Intellijoint Navigation System: Workstation G2 Configured recalled
Intellijoint Surgical is recalling Intellijoint Navigation System: Workstation G2 Configured, distributed nationwide in the US. The recall was initiated on 28 Aug 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0119-2027
- FDA event ID
- 99821
- Recalling firm
- Intellijoint Surgical, Kitchener, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 28 Aug 2026
- FDA classified
- 7 Oct 2026
- Reported
- 14 Oct 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Hip & Knee Implants
Timeline
| 28 Aug 2026 | Recall initiated by company | |
| 7 Oct 2026 | Classified by FDA | +40 days |
| 14 Oct 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Intellijoint Navigation System: Workstation G2 Configured, REF: 000-0241; Intellijoint HIP Cart System, REF: 000-0250; Intellijoint HIP, Portable System, REF: 000-0249
Where it was distributed
Worldwide - US Nationwide distribution in the states of CA, TX, MS, NJ and the countries of Singapore, Spain.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
REF/UDI-DI/MacBook Serial Numbers: 000-0241/00628184002414/C02RP36YG8WP, C02QPCF5G8WN 000-0250/00628184002506/C02RF44TG8WN, C02QW25RG8WL, C02QH355G8WM, C02S22N9G8WP; 000-0249/00628184002490/C02RQ3FUG8WN, C02R4451G8WN
Where was it sold?
Worldwide - US Nationwide distribution in the states of CA, TX, MS, NJ and the countries of Singapore, Spain.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Intellijoint Surgical
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Intellijoint Navigation System recalled by Intellijoint Surgical | Intellijoint Surgical | Device Malfunction | Nationwide |
| Device | CLASS II | Workstation, G2, Configured recalled by Intellijoint Surgical | Intellijoint Surgical | Device Malfunction | 5 states |
Other Hip & Knee Implants recalls
All 3,111| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large recalled | New York Embroidery Studio | Packaging Defects | Nationwide |
| Device | CLASS II | Axle Pin Assy Large Elbow Cobalt Chrome recalled by Howmedica Osteonics | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Triathlon Hinge Insert Size 4 5612-p-411 Triathlon Hinge recalled | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Scorpio Recessed Metal Backed Patella 3045 recalled | Howmedica Osteonics | Foreign Material | Nationwide |
| Device | CLASS II | Bearing And Axle Bushing Assy Std Elbow C-m113-1-301 Krh recalled | Howmedica Osteonics | Other | Nationwide |