GRACE MEDICAL FLUOROPLASTIC PISTON 402-450Recalls & reported problems
Grace Medical, Inc. · FLUOROPLASTIC PISTON 0.6MM DIA X 4.50MM L · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 00844505000567), received between Aug 26, 2021 and Aug 26, 2021 — classified as 1 injury.
1 other recall cover devices cleared under the same FDA submission (K060518); 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 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hearing Impairment1
- Inflammation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 26, 2021Adverse Event Without Identified Device or Use Problem
IT WAS INITIALLY REPORTED THAT "THERE IS PATIENT LOSS HEARING AFTER OPERATION OF FLUOROPLASTIC PISTON. THE PATIENT HEAR FOR THE FIRST 3 DAYS AFTER OPERATION THEN LOSS HEARING." IT WAS LATER REPORTED "AFTER THE OPERATION, THE PATIENT LOSS HEARING FOR 3 DAYS THEN RETURNED HEAR THAT IS BECAUSE OF THE PATIENT WAS SUFFERING FROM INFLAMMATION THEN HE TREATED FROM THIS INFLAMMATION."
Patient problems: Hearing Impairment; Inflammation
MAUDE report 12374241 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K060518. One submission often covers many models, so check the product and lot details in each record.
- Z-2308-2026 · Apr 3, 2026 · Open, ClassifiedTITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Prosthesis
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
- PARTIAL 3MM CENTERED HEAD 270Grace Medical, Inc. · PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT1 report
- CENTERED ALTO CONCISE PARTIAL 655-075Grace Medical, Inc. · Prosthesis, Partial Ossicular Replacement1 report
- N/A 1160000Medtronic Xomed, 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page