SMART 70145923Recalls & reported problems
Gyrus ACMI, LLC · SMART STAPES PISTON 0.5 MM X 4.50 MM NITINOL FLUOROPLASTIC · Class 2 · Implant
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821925023697), received between Jun 2, 2022 and Jun 2, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Migration” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K003214); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Migration1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 2, 2022Migration; Migration
THE CUSTOMER REPORTED TO OLYMPUS THE IMPLANT FELL OUT OF 'THE WINDOW.' THE PATIENT WENT TO HIS PHYSICIAN AFTER HAVING INCREASED PRESSURE WHEN SHOVELING SNOW. THE PISTON WAS DISPLACED. IT IS UNCLEAR IF THE PATIENT WAS HARMED OR INJURED BY THE DISPLACED IMPLANT. THE INDICATION FOR THE IMPLANT IS UNKNOWN. THE ORIGINAL IMPLANT DATE WAS (B)(6) 2021. IT IS UNKNOWN IF THERE WERE ANY ISSUES DURING IMPLANTATION OR IF THE IMPLANT WAS SECURELY PLACED. THERE WAS NO DIFFICULTY REMOVING THE IMPLANT.
Patient problems: Foreign Body In Patient
MAUDE report 14575425 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K003214. One submission often covers many models, so check the product and lot details in each record.
- Z-2813-2020 · Jul 14, 2020 · TerminatedSmart Stapes Protheses Piston 0.4mm X 5.25 mm- Partial Ossicular Replacement Catalog Number: 70142168
- Z-2814-2020 · Jul 14, 2020 · TerminatedSmart Stapes Protheses Piston 0.6mm X 4.25 mm- Partial Ossicular Replacement Catalog Number: 70143662
Other Prosthesis, Partial Ossicular Replacement devices
- TITANIUM/FLUOROPLASTIC PISTON 409-375Grace Medical, Inc. · PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT1 recall0 reports
- NA 1150001Medtronic Xomed, Inc. · PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT3 reports
- SMART 70145928Gyrus ACMI, LLC · Prosthesis, Partial Ossicular Replacement3 reports
- The Big Easy® 1156603Medtronic Xomed, Inc. · PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT2 reports
- NA 1150000Medtronic Xomed, Inc. · PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT2 reports
- The Big Easy® 1156602Medtronic Xomed, Inc. · PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT1 report
- N/A 1160000Medtronic Xomed, Inc. · PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT1 report
- CENTERED ALTO CONCISE PARTIAL 655-075Grace Medical, Inc. · Prosthesis, Partial Ossicular Replacement1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.