NA 2611-30-000Recalls & reported problems
Depuy Orthopaedics, Inc. · CORE CASE 1 INSTRUMENT CASE COMPLETE · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295149255), received between Jun 29, 2022 and Jun 29, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Most reported problems
Device problems
- Break2
- Crack2
- Peeled/Delaminated2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 29, 2022Break; Crack; Peeled/Delaminated; Break; Crack; Peeled/Delaminated
ON (B)(6) 2022 THE SPD DEPARTMENT AT NORTH CHICAGO VA (UCN 400422) DENIED THE DELIVERY OF SIX TRAYS. THE HOSPITAL STAFF OBSERVED DAMAGE ON THE BRACKETS WHICH HOLD THE INSTRUMENTS IN PLACE WITHIN THE GRAPHIC CASES AS WELL AS THE GENERAL CONDITION OF THE PLASTIC TRAY INSERTS. THIS ISSUE WAS IDENTIFIED ON (B)(6) AND REPLACEMENT TRAYS WERE DELIVERED ON (B)(6) FOR THE CASE THAT WAS SCHEDULED ON (B)(6). CONSULTANT CONFIRMED THAT THERE WAS NO IMPACT OR DELAY IN SURGICAL SCHEDULE DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14857125 ↗MalfunctionJun 29, 2022Break; Crack; Peeled/Delaminated; Break; Crack; Peeled/Delaminated
ON (B)(6) 2022 THE SPD DEPARTMENT AT (B)(6) DENIED THE DELIVERY OF SIX TRAYS. THE HOSPITAL STAFF OBSERVED DAMAGE ON THE BRACKETS WHICH HOLD THE INSTRUMENTS IN PLACE WITHIN THE GRAPHIC CASES AS WELL AS THE GENERAL CONDITION OF THE PLASTIC TRAY INSERTS. THIS ISSUE WAS IDENTIFIED ON (B)(6) AND REPLACEMENT TRAYS WERE DELIVERED ON JUNE 6TH FOR THE CASE THAT WAS SCHEDULED ON (B)(6). CONSULTANT CONFIRMED THAT THERE WAS NO IMPACT OR DELAY IN SURGICAL SCHEDULE DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14855322 ↗
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
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page