Stimulator, Invasive Bone Growth
FDA adverse event reports and recall history for stimulator, invasive bone growth (product code LOE), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 140
- Deaths
- 2
- Injuries
- 75
- Malfunctions
- 56
Reports per year
Source: FDA adverse event reports by year received, 2011–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2017-05-26TerminatedOther
10-1335M - SpF-XL IIB 2/DM Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.
Zimmer Biomet is conducting a medical device field action for the SpF PLUS-Mini and SpF XL IIB Implantable Spinal Fusion Stimulator products due to higher than allowed cytotoxicity levels found during routine process monitoring with the product.
- 2017-05-26TerminatedOther
10-1398M - SpF-PLUS Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.
Zimmer Biomet is conducting a medical device field action for the SpF PLUS-Mini and SpF XL IIB Implantable Spinal Fusion Stimulator products due to higher than allowed cytotoxicity levels found during routine process monitoring with the product.
- TerminatedUnder Investigation by firm
EBI Osteogen Implantable Bone Growth Stimulator The OsteoGen Implantable Bone Growth Stimulator is indicated in the treatment of long bone nonunions.
Lack of adequate validation and controls to ensure that product cleanliness parameters were consistently met.
- TerminatedUnder Investigation by firm
SpF PLUS-Mini (60 A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
Lack of adequate validation and controls to ensure that product cleanliness parameters were consistently met.
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