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STAR™ 400-250Recalls & reported problems

Stryker GmbH · Talar Component, Single Coated/US Version XX-SMALL, RIGHT · Class 3 · Implant

All models of STAR (22)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00886385016412), received between Aug 28, 2015 and Aug 28, 2015 — classified as 1 injury.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Device Operates Differently Than Expected1

Patient problems

  • No Code Available1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 28, 2015Device Operates Differently Than Expected

    PATIENT PRESENTED WITH ANKLE PAIN. XRAY AND CT SHOWED CYSTS IN THE DISTAL TIBIA. THE TALUS COMPONENT WAS PUSHED ANTERIOR. OPERATION- POSTERIOR INCISION TO I & D THE CYST IN DISTAL POSTERIOR TIBIA, BACK FILLED WITH ALLOGRAFT AND HYDROSET, PLATED WITH TWO SYNTHES DISTAL TIBIA PLATES. PATIENT WAS FLIPPED AND ANTERIOR INCISION WAS MADE. THE TALUS WAS REVISED BY REPLACING AND MOVING THE COMPONENT MORE POSTERIOR TO SET UNDER THE TIBIA. THE POLY WAS EXCHANGED AND A TAL WAS PREFORMED.

    Patient problems: No Code Available

    MAUDE report 5038460 ↗

Other Prosthesis, Ankle, Uncemented, Non-Constrained devices

All Prosthesis, Ankle, Uncemented, Non-Constrained devices →

Sources and updates

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