PINNACLE 2220-00-110Recalls & reported problems
Depuy (Ireland) · PINNACLE CORE CASE · Class 1
Quick summary
This DePuy Pinnacle surgical instrument tray is used to hold and carry instruments during surgery. The 27 reports all describe the black plastic coating peeling or delaminating from the metal framing, with flakes sometimes coming loose inside the tray. None report a death, an injury, or a patient consequence, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 27
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10603295424185), received between Mar 23, 2021 and May 28, 2026 — classified as 27 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (27 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Peeled/Delaminated27
Patient problems
- No Clinical Signs, Symptoms or Conditions27
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 28, 2026Peeled/Delaminated
IT WAS REPORTED THAT THE TRAYS ARE STARTING TO PEEL IN THE INSIDES DUE TO WEAR AND TEAR. NO DELAYS NOTHING LEFT INSIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25313481 ↗MalfunctionMay 28, 2026Peeled/Delaminated
IT WAS REPORTED THAT THE TRAYS ARE STARTING TO PEEL IN THE INSIDES DUE TO WEAR AND TEAR. NO DELAYS NOTHING LEFT INSIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25313292 ↗MalfunctionMay 28, 2026Peeled/Delaminated
IT WAS REPORTED THAT THE TRAYS ARE STARTING TO PEEL IN THE INSIDES DUE TO WEAR AND TEAR. NO DELAYS NOTHING LEFT INSIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25313290 ↗MalfunctionMay 28, 2026Peeled/Delaminated
IT WAS REPORTED THAT THE TRAYS ARE STARTING TO PEEL IN THE INSIDES DUE TO WEAR AND TEAR. NO DELAYS NOTHING LEFT INSIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25313289 ↗MalfunctionApr 27, 2026Peeled/Delaminated
IT WAS REPORTED THAT THE BLACK PLASTIC COATING THAT COVERS SOME OF THE METAL FRAMING ON THE TRAY HAS PEELED OFF AND FLAKES INTO THE TRAY WHICH COMPROMISES ITS STERILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24997542 ↗MalfunctionFeb 24, 2026Peeled/Delaminated
IT WAS REPORTED THE PINN CORE TRAYS ARE DELAMINATING. THE EVENT DID NOT HAPPEN IN SURGERY. NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24427290 ↗MalfunctionFeb 24, 2026Peeled/Delaminated
IT WAS REPORTED THE PINN CORE TRAYS ARE DELAMINATING. THE EVENT DID NOT HAPPEN IN SURGERY. NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24427286 ↗MalfunctionFeb 24, 2026Peeled/Delaminated
IT WAS REPORTED THE PINN CORE TRAYS ARE DELAMINATING. THE EVENT DID NOT HAPPEN IN SURGERY. NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24427283 ↗MalfunctionFeb 24, 2026Peeled/Delaminated
IT WAS REPORTED THE PINN CORE TRAYS ARE DELAMINATING. THE EVENT DID NOT HAPPEN IN SURGERY. NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24427282 ↗MalfunctionFeb 24, 2026Peeled/Delaminated
IT WAS REPORTED THE PINN CORE TRAYS ARE DELAMINATING. THE EVENT DID NOT HAPPEN IN SURGERY. NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24427279 ↗MalfunctionFeb 24, 2026Peeled/Delaminated
IT WAS REPORTED THE PINN CORE TRAYS ARE DELAMINATING. THE EVENT DID NOT HAPPEN IN SURGERY. NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24427277 ↗MalfunctionFeb 24, 2026Peeled/Delaminated
IT WAS REPORTED THE PINN CORE TRAYS ARE DELAMINATING. THE EVENT DID NOT HAPPEN IN SURGERY. NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24427269 ↗MalfunctionFeb 24, 2026Peeled/Delaminated
IT WAS REPORTED THE PINN CORE TRAYS ARE DELAMINATING. THE EVENT DID NOT HAPPEN IN SURGERY. NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24427262 ↗MalfunctionJul 1, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT INSTRUMENTS WERE PEELING. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22378517 ↗MalfunctionJul 1, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT INSTRUMENTS WERE PEELING. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22378516 ↗MalfunctionJul 1, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT INSTRUMENTS WERE PEELING. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22378510 ↗MalfunctionJul 8, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT A CORE CASE IS DAMAGED. THE PLASTIC COATING INSIDE THE CASE HAS BEGUN TO LOOSEN. NO IMPACT ON SURGERY OR DELAY FOR PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19689166 ↗MalfunctionJun 21, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE PLASTIC COATING INSIDE THE CASE HAS BEGUN TO LOOSEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19582925 ↗MalfunctionJun 7, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT A CORE CASE IS DAMAGED. THE PLASTIC COATING INSIDE THE CASE HAS BEGUN TO LOOSEN. NO IMPACT ON SURGERY OR DELAY FOR PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19484816 ↗MalfunctionMar 27, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE TRAYS WERE PEELING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18987168 ↗MalfunctionMar 26, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT TRAYS WERE PEELING. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18984319 ↗MalfunctionNov 29, 2023Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE TRAYS PRESENTED WERE CHIPPING. CALLED FOR NEW SETS.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18226850 ↗MalfunctionApr 27, 2023Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT PAINT FLAKES OFF CREATING CONTAMINATION ISSUE FOR HOSPITAL. SURGICAL DELAY WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16824201 ↗MalfunctionSep 21, 2021Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE TRAY HAS COLOR FLAKES, AND CANNOT BE STERILIZED PROPERLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12510893 ↗MalfunctionMay 11, 2021Peeled/Delaminated; Peeled/Delaminated
PLASTIC TORN SEE PICTURE. NO REPORTED SURGICAL DELAYS OR PATIENT CONSEQUENCES. NO MORE INFO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11805492 ↗
Other TRAY, SURGICAL, INSTRUMENT devices
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- ATTUNE 2545-01-703Depuy (Ireland) · TRAY, SURGICAL, INSTRUMENT62 reports
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- n.a. 39501CECKarl Storz GmbH & Co. KG · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.