INBONE 200252903Recalls & reported problems
Wright Medical Technology, Inc. · Class 2 · Implant
All models of INBONE (56)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00840420124142), received between Feb 18, 2025 and Dec 4, 2025 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
1 FDA recall record name this device's identifier.
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
Recalls naming this device
- Sep 30, 2022Terminated
The tibial tray lock detail is oversized (larger than specification).
Z-0139-2023 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Insufficient Device Problem Information1
- Positioning Failure1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- Post Operative Wound Infection1
- Unspecified Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 4, 2025Positioning Failure; Positioning Failure
THE POLY TRIALS WOULD DISENGAGE WHEN THE DOCTOR WOULD TRY TO FULLY SEAT THEM INTO THE TIBIAL TRAY DOVE TAILS. ALL PRECAUTIONARY ACTIONS WERE TAKEN TO ENSURE NOTHING WAS IMPEDING THE POLY TRIAL FROM SEATING CORRECTLY. THE PHYSICIAN BELIEVES THE MACHINING OF THE DOVE TAILS ON THE TIBIAL TRAY WERE NOT EVEN ON BOTH SIDES. SPECIFICALLY, THE LATERAL SIDE DOVE TAIL WAS MORE PARALLEL (UP AND DOWN) THAN THE MEDIAL SIDE, WHICH SEEMED TO HAVE MORE OF AN ANGLED CUT. FINAL POLY IMPLANT WAS ABLE TO SEAT WITH MINIMAL COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23717295 ↗InjuryMay 27, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT UNDERWENT A DEVICE EXPLANT SURGERY FOR REASONS THAT ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information; Post Operative Wound Infection
MAUDE report 22092593 ↗InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE DIGITAL STRYKER PROPHECY TEAM RECEIVED A CT SCAN INDICATING THAT THE PATIENT MAY REQUIRE A REVISION SURGERY DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 21399710 ↗
Other PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER devices
- Vantage 350-22-03Exactech, Inc. · Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer2 recalls2 reports
- Vantage 350-21-04Exactech, Inc. · Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer2 recalls0 reports
- INFINITY 33630023Wright Medical Technology, Inc. · PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER60 reports
- INFINITY 33600020Wright Medical Technology, Inc. · PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall9 reports
- Vantage 350-22-02Exactech, Inc. · Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1 recall5 reports
- INFINITY 33650003Wright Medical Technology, Inc. · PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER55 reports
- INFINITY 33630022Wright Medical Technology, Inc. · PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER54 reports
- INFINITY 33600030Wright Medical Technology, Inc. · PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall4 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 · each recall links to the FDA recall notice
- 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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