Titan Modular Shoulder System 2.5 IMP-0926-030-02ARecalls & reported problems
Smith & Nephew, Inc. · COMBO INSERTER/IMPACTOR. M · Class 1
All models of Titan Modular Shoulder System 2.5 (13)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556860748), received between Apr 6, 2023 and Jan 11, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Fracture2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 11, 2024Fracture; Fracture
IT WAS REPORTED THAT, DURING TSA SURGERY, ONE (1) COMBO INSERTER/IMPACTOR. M BROKE DURING THE CASE. NO X-RAYS AVAILABLE, ITEM DID NOT BROKE INSIDE PATIENT AND NO PIECES WERE LEFT IN PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18490767 ↗MalfunctionApr 6, 2023Fracture; Fracture
IT WAS REPORTED THAT, DURING A TSA SURGERY, ONE (1) COMBO INSERTER/IMPACTOR. M BROKE WHILE INSERTING THE FIN LOCK GLENOID INTO PATIENT. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED; HOWEVER, NO SURGICAL DELAY WAS REPORTED. PATIENT WAS NOT INJURED DUE TO THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16690400 ↗
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- INHANCE 6205-10-103Depuy (Ireland) · IMPACTOR337 reports
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.
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