CLASS II Device recall · Reported 5 Nov 2025 · FDA Enforcement Report
Surgical Planner, BrainSTORM recalled by Surgical Theater
Surgical Theater is recalling Surgical Planner, BrainSTORM, distributed nationwide in the US. The recall was initiated on 16 Sep 2025 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-0325-2026
- FDA event ID
- 97715
- Recalling firm
- Surgical Theater, Beachwood, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Sep 2025
- FDA classified
- 24 Oct 2025
- Reported
- 5 Nov 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Hip & Knee Implants
Timeline
| 16 Sep 2025 | Recall initiated by company | |
| 24 Oct 2025 | Classified by FDA | +38 days |
| 5 Nov 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer.
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
Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented reality
Where it was distributed
Worldwide - US Nationwide distribution in the states of MI, FL, DC, MN, CA, TX, NJ, PA, AZ, NY, KY, IN, WV and the countries of Italy, Germany, Israel, UK.
Nationwide ArizonaCaliforniaDistrict of ColumbiaFloridaIndianaKentuckyMichiganMinnesotaNew JerseyNew YorkPennsylvaniaTexasWest Virginia
Questions about this recall
Why was it recalled?
A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer.
Which lots are affected?
UDI/DI 00860003884119
Where was it sold?
Worldwide - US Nationwide distribution in the states of MI, FL, DC, MN, CA, TX, NJ, PA, AZ, NY, KY, IN, WV and the countries of Italy, Germany, Israel, UK.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
6 other products · FDA event 97715This product is part of a recall event; the main page for the event is SuRgical Planner (SRP) recalled by Surgical Theater.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | SuRgical Planner (SRP) recalled by Surgical Theater | Surgical Theater | Device Malfunction | Nationwide | |
| CLASS II | Endo Surgical Navigation Advanced Platform Patient recalled | Surgical Theater | Device Malfunction | Nationwide | |
| CLASS II | SpineAR Surgical Navigation Advanced Platform Patient recalled | Surgical Theater | Device Malfunction | Nationwide | |
| CLASS II | Surgical Navigation Advanced Platform (SNAP) recalled | Surgical Theater | Device Malfunction | Nationwide | |
| CLASS II | Surgical Navigation Advanced Platform Patient Engagement (PE SNAP) recalled | Surgical Theater | Device Malfunction | Nationwide | |
| CLASS II | SyncAR Surgical Navigation Advanced Platform Patient recalled | Surgical Theater | Device Malfunction | Nationwide |
More recalls from Surgical Theater
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | SyncAR Surgical Navigation Advanced Platform Patient recalled | Surgical Theater | Device Malfunction | Nationwide |
| Device | CLASS II | Surgical Navigation Advanced Platform Patient Engagement (PE SNAP) recalled | Surgical Theater | Device Malfunction | Nationwide |
| Device | CLASS II | Surgical Navigation Advanced Platform (SNAP) recalled | Surgical Theater | Device Malfunction | Nationwide |
| Device | CLASS II | SpineAR Surgical Navigation Advanced Platform Patient recalled | Surgical Theater | Device Malfunction | Nationwide |
| Device | CLASS II | Endo Surgical Navigation Advanced Platform Patient recalled | Surgical Theater | Device Malfunction | Nationwide |
Other Hip & Knee Implants recalls
All 3,111| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Intellijoint Navigation System: Workstation G2 Configured recalled | Intellijoint Surgical | Device Malfunction | Nationwide |
| 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 |