ATTUNE 2545-01-967Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295423393), received between Oct 5, 2017 and Feb 21, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

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.

Recalls naming this device

1. Jun 12, 2015Terminated

   Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to become damaged and disassociate (come off). If the Balseal is separated from the post, it has the potential to enter the surgical site and be left in the patient if the surgeon is unaware of the disassociation.

   Z-2146-2015 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 21, 2023Break; Break

  IT WAS REPORTED THAT THE SPRING IN SHIM BROKE OFF. NO SURGICAL DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16412503 ↗
• MalfunctionJan 17, 2022Break; Break

  INSTRUMENT IS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13266530 ↗
• MalfunctionOct 5, 2017Break; Break

  IT WAS REPORTED THAT THE COIL CAME OFF THE ARTICULATING SURFACE. THIS WAS HAPPENED WHEN THE SCRUB NURSE WAS UNCLIPPING IT FROM ONE OF THE TIBIAL SHIMS ON THE BACK TABLE.

  Patient problems: No Information

  MAUDE report 6918261 ↗