PINNACLE 2217-60-007Recalls & reported problems
Depuy (Ireland) · PINNACLE TRIAL LINER TRAY 48-66 · Class 1
All models of PINNACLE (198)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295099215), received between Aug 17, 2020 and Apr 27, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (2 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.
Reports received per month
Most reported problems
Device problems
- Peeled/Delaminated2
- Contamination /Decontamination Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Code Available1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 27, 2026Peeled/Delaminated
IT WAS REPORTED THAT AFTER REPEATED USAGE THE PAN GRADUALLY STARTED BREAKING DOWN AND WAS NO LONGER COMPLIANT. IT WAS REPORTED THAT THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25002306 ↗MalfunctionNov 29, 2021Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE BOTTOM OF THE TRAYS ARE FALLING APART OVER TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12883606 ↗MalfunctionAug 17, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT A LOANER SET OF INSTRUMENTS WAS RECEIVED BACK FROM A HOSPITAL THAT CONTAINED RESIDUAL DEBRIS AND HAD TO BE RETURNED TO THE SITE FOR ADDITIONAL CLEANING BY THEIR STERILE PROCESSING DEPARTMENT.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 10417465 ↗
Other TRAY, SURGICAL, INSTRUMENT devices
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- ATTUNE 2545-01-703Depuy (Ireland) · TRAY, SURGICAL, INSTRUMENT62 reports
- ATTUNE 2545-01-704Depuy (Ireland) · TRAY, SURGICAL, INSTRUMENT57 reports
- Calibrate CLCCXSIMPAAlphatec Spine, Inc. · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- n.a. 39501BECKarl Storz GmbH & Co. KG · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- n.a. 39501XKKarl Storz GmbH & Co. KG · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- n.a. 39501A2Karl Storz GmbH & Co. KG · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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