STAR™ 925-0016Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00886385018102), received between Sep 25, 2015 and Sep 25, 2015 — classified as 1 injury.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

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

• InjurySep 25, 2015Break; Fracture; Positioning Problem

  DURING A STRYKER EVENT WITH THE SURGICAL TEAM ON (B)(6), THE SURGEON, REPORTED TO THE MARKETING MANAGER, THAT DURING A STAR ANKLE PROCEDURE, ON THE (B)(6), THE DISC ON THE ANTERIOR CHAMFER REAMER HAD BROKEN ALLOWING THE SURGEON TO DRILL TOO FAR INTO THE BONE. THE SURGEON FURTHER REPORTED THAT THIS CAUSED A FRACTURE TO THE TALUS BONE AND THE SURGEON HAD TO CARRY OUT A GRAFT.

  Patient problems: Bone Fracture(s)

  MAUDE report 5104308 ↗