ESC PINNACLE 2217-60-063Recalls & reported problems
Depuy (Ireland) · PINNACLE ESC CONSTRAINED LINERS INST CASE COMPLETE · Class 1
All models of ESC PINNACLE (5)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295099345), received between Jul 1, 2025 and Jul 1, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Peeled/Delaminated” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Peeled/Delaminated1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 1, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE PAN WAS PEELING, THE PINNACLE SCREW SET CASE WAS PEELING, 1 UNKNOWN PRODUCT WAS CRACKED AND ANOTHER UNKNOWN PRODUCT WAS ALSO PEELING. THE EVENT DID NOT HAPPENED DURING A SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22378545 ↗
Other TRAY, SURGICAL, INSTRUMENT devices
- PINNACLE 2220-00-100Depuy (Ireland) · TRAY, SURGICAL, INSTRUMENT74 reports
- ACTIS 2010-04-200Depuy (Ireland) · TRAY, SURGICAL, INSTRUMENT66 reports
- ATTUNE 2545-01-703Depuy (Ireland) · TRAY, SURGICAL, INSTRUMENT62 reports
- ATTUNE 2545-01-704Depuy (Ireland) · TRAY, SURGICAL, INSTRUMENT57 reports
- n.a. 39501XKarl Storz GmbH & Co. KG · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- Medical Action Industries 6810Medical Action Industries 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
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page