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
- 5,835
- Deaths
- 14
- Injuries
- 3,969
- Malfunctions
- 1,849
Reports per year
Source: FDA adverse event reports by year received, 1996–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerJWH1,294
- Electrosurgical, Cutting & Coagulation & AccessoriesGEI417
- Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/PolymerKRO361
- Clip, ImplantableFZP309
- Orthopedic Manual Surgical InstrumentLXH215
- Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/PolymerHRY213
- Appliance, Fixation, Spinal Intervertebral BodyKWQ201
- Prosthesis, Intervertebral DiscMJO165
- Knee Arthroplasty Implantation SystemOOG144
- Thoracolumbosacral Pedicle Screw SystemNKB141
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."
Monitor Aesculap Ag 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.