ATTUNE 2545-01-715Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295452478), received between Jun 24, 2022 and Jan 27, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (11 reports).

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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2026Peeled/Delaminated

  IT WAS REPORTED THAT DURING THE STERILIZATION PROCESS. IT WAS OBSERVED THAT THE COLOR FROM THE TRAY CAME OFF. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24193436 ↗
• MalfunctionNov 7, 2025Peeled/Delaminated; Peeled/Delaminated

  THIS IS REPORT 3 OF 3 OF (B)(4). IT WAS REPORTED THAT DURING A KNEE SURGICAL PROCEDURE IT WAS OBSERVED THAT 3X ATT TIB PREP PLUS-IMPACT DEVICES HAD PAINT CHIPPING ON THE EXTERIOR OF THE TRAY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23500856 ↗
• MalfunctionNov 7, 2025Peeled/Delaminated; Peeled/Delaminated

  THIS IS REPORT 1 OF 3 OF (B)(4). IT WAS REPORTED THAT DURING A KNEE SURGICAL PROCEDURE IT WAS OBSERVED THAT 3X ATT TIB PREP PLUS-IMPACT DEVICES HAD PAINT CHIPPING ON THE EXTERIOR OF THE TRAY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23500795 ↗
• MalfunctionNov 7, 2025Peeled/Delaminated; Peeled/Delaminated

  THIS IS REPORT 2 OF 3 OF (B)(4). IT WAS REPORTED THAT DURING A KNEE SURGICAL PROCEDURE IT WAS OBSERVED THAT 3X ATT TIB PREP PLUS-IMPACT DEVICES HAD PAINT CHIPPING ON THE EXTERIOR OF THE TRAY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23500793 ↗
• MalfunctionFeb 4, 2025Crack; Peeled/Delaminated; Crack; Peeled/Delaminated

  IT WAS REPORTED THAT THE HOSPITAL COMPLAINT ABOUT TRAYS CHIPPING, PEELING, CRACKING AND THE OUTER RUBBER PEELING OFF. IT WAS REPORTED THAT THE CHIPPING DID NOT HAPPEN IN SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21309093 ↗
• MalfunctionFeb 4, 2025Crack; Peeled/Delaminated; Crack; Peeled/Delaminated

  IT WAS REPORTED THAT THE HOSPITAL COMPLAINT ABOUT TRAYS CHIPPING, PEELING, CRACKING AND THE OUTER RUBBER PEELING OFF. IT WAS REPORTED THAT THE CHIPPING DID NOT HAPPEN IN SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21308747 ↗
• MalfunctionFeb 4, 2025Crack; Peeled/Delaminated; Crack; Peeled/Delaminated

  IT WAS REPORTED THAT THE HOSPITAL COMPLAINT ABOUT TRAYS CHIPPING, PEELING, CRACKING AND THE OUTER RUBBER PEELING OFF. IT WAS REPORTED THAT THE CHIPPING DID NOT HAPPEN IN SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21308508 ↗
• MalfunctionDec 11, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT PANS DIDN'T HAVE LABELS ON THEM ANYMORE. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20907109 ↗
• MalfunctionDec 11, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT PANS DIDN'T HAVE LABELS ON THEM ANYMORE. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20906814 ↗
• MalfunctionDec 11, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT PANS DIDN'T HAVE LABELS ON THEM ANYMORE. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20906794 ↗
• MalfunctionJul 18, 2023Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE PAN INNER LINING WAS PEELING AND WAS UNACCEPTABLE TO SPD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17342118 ↗
• MalfunctionJun 24, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ATTUNE PRIMARY TIBIAL PREP TRAY ZZINNZK0857 IS LEAVING RESIDUE FROM THE LINING OF THE METAL TRAY ON THEIR INSTRUMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14802951 ↗