CENTERED ALTO CONCISE PARTIAL 655-075Recalls & reported problems
Grace Medical, Inc. · CENTERED ALTO CONCISE PARTIAL SIZERS INCLUDED TITANIUM/SILICONE · Class 2 · Implant
- 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 00844505013383), received between Mar 10, 2025 and Mar 10, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Damaged Prior to Receipt by User” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Device Damaged Prior to Receipt by User1
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.
MalfunctionMar 10, 2025Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User
GRACE MEDICAL CUSTOMER SERVICE WAS MADE AWARE OF A PRODUCT FAILURE VIA E-MAIL. THE COMPLAINT CAPTURED AND REGULATORY WAS NOTIFIED VIA A MEDSUN REPORT UF/IMPORTER REPORT # (B)(4) BY THE FDA. THE USER FACILITY REPORTED THAT THE IMPLANT WAS UNCAPPED AND LOOSE WHEN PEEL PACK WAS OPENED TO THE STERILE FIELD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21564939 ↗
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
- Gyrus ACMI 70140801Gyrus ACMI, LLC · 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.