PINNACLE 2220-00-210Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295424284), received between Mar 3, 2020 and Jan 6, 2026 — classified as 8 malfunctions.

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

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2026Break; Peeled/Delaminated

  IT WAS REPORTED THAT THE SETS ARE PEALING, AND BROKEN INSERTS. IT WAS REPORTED THAT IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23980939 ↗
• MalfunctionJul 2, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE PINNACLE UTILITY CASE AND ACTIS CORE CASE BASE ARE PEELING, ACTIS FLX REAMER CASE BASE REPORTED FOR AN UNKNOWN REASON. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22384220 ↗
• MalfunctionJul 1, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE DEVICE WAS PEELING, IT DIDN'T HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22378365 ↗
• MalfunctionJan 7, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE PRIMARY HIP SURGERY WAS DONE ON (B)(6) 2024 , WHILE REASSEMBLING THE INSTRUMENTS THE FOLLOWING DAY, IT WAS NOTICED THAT THE BLACK LABELING ON THE SIDE OF THE TRAY HAS STARTED TO COME OFF. THIS TRAY WAS A PINNACLE OFFSET HANDLES TRAY. THE TRAY HAS BEEN REMOVED FROM USE UPON NOTICING THIS. THE SURGICAL DELAY WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21092032 ↗
• MalfunctionMay 16, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE FOLLOWING DEVICE WAS RECEIVED AS BLIND UNIT. ADDITIONAL EVENT INFORMATION: VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT PINNACLE UTILITY CASE HAS THE PLASTIC COATING OF THE BRACKETS PEELING OFF. ADDITIONALLY, SIGNS OF DEFORMATION WERE OBSERVED ON THREE (3) BRACKETS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19336851 ↗
• MalfunctionMay 9, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE FOLLOWING DEVICE WAS RECEIVED AS BLIND UNIT. ADDITIONAL EVENT INFORMATION: VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT PINNACLE UTILITY CASE HAS THE PLASTIC COATING OF THE BRACKETS PEELING OFF ADDITIONALLY, THE DEVICES EXHIBITS AN OVERALL WORN APPEARANCE CONSISTENT WITH NORMAL AND CONSTANT USAGE FOR OVER 6 YEARS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19280903 ↗
• MalfunctionMay 9, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE FOLLOWING DEVICE WAS RECEIVED AS BLIND UNIT. ADDITIONAL EVENT INFORMATION: VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT PINNACLE UTILITY CASE HAS THE PLASTIC COATING OF THE BRACKETS PEELING OFF. ADDITIONALLY, SIGNS OF DEFORMATION WERE OBSERVED ON TWO (2) BRACKETS. THE OVERALL APPEARANCE OF THE DEVICE EXHIBITS EVIDENCE OF CONSTANT USE, SERVICING AND REPETITIVE STERILIZATION CYCLES FOR OVER 5 YEARS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19280902 ↗
• MalfunctionMar 3, 2020Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE BRACKETS INSIDE OF TRAY IS PEELING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9781640 ↗