Prosthesis, Partial Ossicular Replacement
FDA adverse event reports and recall history for prosthesis, partial ossicular replacement (product code ETB), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 100
- Deaths
- 0
- Injuries
- 55
- Malfunctions
- 34
Reports per year
Source: FDA adverse event reports by year received, 2010–2025. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2026-06-04Open, ClassifiedProcess control
TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Prosthesis
Due to incorrect functional length on device labeling.
- TerminatedPackaging process control
Smart Stapes Protheses Piston 0.4mm X 5.25 mm- Partial Ossicular Replacement Catalog Number: 70142168
Mislabeled outer carton: packaged with the outer carton label stating the contents were the 70143662 Smart Piston but the inside package contents was the 70142158 Stapes Piston; see image below
- TerminatedPackaging process control
Smart Stapes Protheses Piston 0.6mm X 4.25 mm- Partial Ossicular Replacement Catalog Number: 70143662
Mislabeled outer carton: packaged with the outer carton label stating the contents were the 70143662 Smart Piston but the inside package contents was the 70142158 Stapes Piston; see image below
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