INBONE IB200031Recalls & reported problems
Wright Medical Technology, Inc. · Dome Strike Tip, Sulcus · Class 1
All models of INBONE (56)
Data updated Oct 16, 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 00889797047999), received between May 18, 2022 and Nov 9, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Most reported problems
Device problems
- Break2
- Fracture2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 9, 2022Break; Fracture; Break; Fracture
IT WAS REPORTED THAT AFTER SUCCESSFULLY IMPLANTING THE TALAR DOME OF THE INFINITY ANKLE REPLACEMENT, THE TALAR TIP IMPACTOR HAD SNAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15758591 ↗MalfunctionMay 18, 2022Break; Fracture; Break; Fracture
STRYKER REP REPORTED THAT THE IMPACTOR BROKE DURING THE CASE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 14427467 ↗
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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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