Flex H/A® 1150000Recalls & reported problems
Medtronic Xomed, Inc. · PROSTHESIS 1150000 UNIV TITAN RND HEAD · 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 00763000036195), received between Sep 27, 2024 and Sep 27, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
1 other recall cover devices cleared under the same FDA submission (K002897); 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.
Reports received per month
Most reported problems
Device problems
- Break1
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.
MalfunctionSep 27, 2024Break; Break
IT WAS REPORTED THAT DURING THE SURGERY, WHEN PREPARING FOR IMPLANTATION, IT WAS FOUND THAT THE OSSICULAR PROSTHESIS WAS BROKEN IN T WO PIECES AND COULD NOT BE IMPLANTED OR USED NORMALLY. THIS WAS THE FIRST TIME THE OSSICULAR PROSTHESIS WAS USED. THE PROSTHESIS WAS NOT BROKEN WHEN IT WAS RECEIVED. THE PROCEDURE WAS EXTENDED BY 2 MINUTES AND WAS COMPLETED WITH A BACKUP PRODUCT. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20319201 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K002897. One submission often covers many models, so check the product and lot details in each record.
- Z-2284-2013 · Aug 23, 2013 · TerminatedUniversal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss.
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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