Aesculap Ag
FDA adverse event reports naming Aesculap Ag as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: AESCULAP AG.
- Total reports
- 5,922
- Deaths
- 15
- Injuries
- 4,051
- Malfunctions
- 1,853
Reports per year
Source: FDA adverse event reports by year received, 1996–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Top device categories
- Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerJWH1,341
- Electrosurgical, Cutting & Coagulation & AccessoriesGEI419
- Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/PolymerKRO362
- Clip, ImplantableFZP311
- Orthopedic Manual Surgical InstrumentLXH218
- Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/PolymerHRY213
- Appliance, Fixation, Spinal Intervertebral BodyKWQ207
- Prosthesis, Intervertebral DiscMJO165
- Knee Arthroplasty Implantation SystemOOG147
- Thoracolumbosacral Pedicle Screw SystemNKB142
Recent recalls
- 2025-10-02Open, ClassifiedProcess control
AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.
Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."
- 2025-10-02Open, ClassifiedProcess control
AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R.
Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."
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