Stimulator, Bone Growth, Non-Invasive
FDA adverse event reports and recall history for stimulator, bone growth, non-invasive (product code LOF), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 1,424
- Deaths
- 5
- Injuries
- 1,372
- Malfunctions
- 34
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2024-04-23Open, ClassifiedDevice Design
Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones, Part Number: 1067716
Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment
- 2024-04-23Open, ClassifiedDevice Design
Biomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones. Part Number: 1067718
Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment
- 2024-04-23Open, ClassifiedDevice Design
20" Lead Wires, Replacement Part Number: 1067724-2
Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment
- 2024-04-23Open, ClassifiedDevice Design
48" Lead Wires, Replacement Part Number: 1067724-4
Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment
- TerminatedNonconforming Material/Component
EXOGEN Ultrasound Coupling Gel
Product may contain white particulates that are microbial in nature.
Monitor stimulator, bone growth, non-invasive automatically
DeviceWatch watches FDA adverse events and recalls for the products you care about, summarizes clinical narratives with AI and alerts you when a safety signal emerges.