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Titan™ IMP096006601Recalls & reported problems

Ascension Orthopedics, Inc. · Titan™ Reverse Shoulder System Glenosphere Impactor The Glenosphere Impactor is used to properly fit the implant and/or trial into the prepared cavity. · Class 1

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 10381780245667), received between Jun 6, 2022 and Jun 6, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

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.

  • MalfunctionJun 6, 2022Break; Break

    IT WAS REPORTED THAT, DURING SURGERY, THE GLENOSPHERE IMPACTOR MOD BROKE WHEN USING TO IMPACT THE GLENOSPHERE. IT IS UNKNWON HOW THE PROCEDURE WAS COMPLETED. NO DELAYS REPORTED. NO PATIENT COMPLICATIONS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14603008 ↗

Other IMPACTOR devices

All IMPACTOR devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.