SMART 70142168Recalls & reported problems
Gyrus ACMI, LLC · SMART STAPES PISTON 0.4MM X 5.25MM TRIMMABLE TO 3.5MM NITINOL FLUOROPLASTIC · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821925021594), received between Jul 28, 2022 and Jul 28, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Separation Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Separation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 28, 2022Separation Problem; Separation Problem
A HEALTHCARE PROFESSIONAL FROM A USER FACILITY REPORTED THAT DURING IMPLANTATION OF THE PROSTHESIS, THE NITINOL PLASTIC SEPARATED FROM THE WIRE. A NEW PROSTHESIS HAD TO BE OPENED. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT REPORTED TO OLYMPUS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15123185 ↗
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-2814-2020 · Jul 14, 2020 · TerminatedSmart Stapes Protheses Piston 0.6mm X 4.25 mm- Partial Ossicular Replacement Catalog Number: 70143662
- Z-2813-2020 · Jul 14, 2020 · TerminatedSmart Stapes Protheses Piston 0.4mm X 5.25 mm- Partial Ossicular Replacement Catalog Number: 70142168
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
- NA 1150000Medtronic Xomed, Inc. · PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT2 reports
- The Big Easy® 1156603Medtronic Xomed, Inc. · PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT2 reports
- GRACE MEDICAL FLUOROPLASTIC PISTON 402-450Grace Medical, Inc. · PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT1 report
- The Big Easy® 1156602Medtronic Xomed, Inc. · PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT1 report
- ECLIPSE FLAT RIBBON PISTON 472-450Grace Medical, Inc. · PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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