Prosthesis, Ankle, Uncemented, Non-Constrained
FDA adverse event reports and recall history for prosthesis, ankle, uncemented, non-constrained (product code NTG), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 1,691
- Deaths
- 18
- Injuries
- 1,579
- Malfunctions
- 93
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
- 2026-06-10Open, ClassifiedLabeling Change Control
Hintermann Series Talar Implant, Left, Size 2 REF 302112
Through customer complaints, the ankle replacement system was found to contain incorrect devices: Left implant packaging and labeling bears a right implant device.
- 2024-01-18Open, ClassifiedPackaging change control
Exactech Vantage Mobile Bearing Tibial Inserts, Catalog Numbers: a) 350-41-23, b) 350-42-03
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
- TerminatedPackaging process control
DT Medical -Hintermann Series H3 Poly Inlay, Size 3 5mm Part Number: 300305 components are prostheses for a mobile bearing ankle joint.
Incorrect package labeling identifying the device
- TerminatedPackaging process control
DT Medi Tech Hintermann Series Talar Implant LEFT-SIZE 4 Part Number: 302114 components are prostheses for a mobile bearing ankle joint.
Incorrect package labeling identifying the device
Monitor prosthesis, ankle, uncemented, non-constrained automatically
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