ATTUNE 2545-00-563Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295133032), received between Jan 21, 2019 and Jun 17, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 18, 2026.

Recalls naming this device

1. Jun 12, 2015Class IITerminated

   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-2141-2015 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2026Break

  IT WAS REPORTED THAT THE SIZE 3 ATTUNE RP CR ARTIC SURF TRIAL WAS BROKEN. THERE WAS NO PATIENT OR USER HARM REPORTED. THERE WAS NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25532058 ↗
• MalfunctionAug 13, 2024Break; Break

  IT WAS REPORTED THAT THERE WERE BROKEN INSTRUMENTS REQUIRING REPLACEMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19974813 ↗
• MalfunctionJun 26, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED INDICATES THAT THERE WAS NO SURGICAL DELAY REPORTED AND THE BROKEN ITEM DID NOT IMPACT THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17199219 ↗
• MalfunctionDec 30, 2021Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  ADDITIONAL INFORMATION RECEIVED STATES THAT IT¿S JUST TWISTED SLIGHTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13118714 ↗
• MalfunctionNov 19, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING THE CONFERENCE OF THE MODULE PK20131N B 4, INSPECTION TEAM, IN LOCAL DC, DETECTED THE LACK OF SPRINGS IN THE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12846925 ↗
• MalfunctionJan 21, 2019Break; Break

  THE TWO ATTUNE RP CR ARTIC SURF SZ3 WERE REPORTED FOR BEING BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8264009 ↗
• MalfunctionJan 21, 2019Break; Break

  THE TWO ATTUNE RP CR ARTIC SURF SZ3 WERE REPORTED FOR BEING BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8263999 ↗