SPECIALIST 96-6552Recalls & reported problems
Depuy (Ireland) · SPECIALIST 2 PATELLAR INST STERILIZATION TRAY - BASE ONLY · Class 1
All models of SPECIALIST (80)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295248873), received between Nov 10, 2022 and Dec 29, 2022 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (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.
Most reported problems
Device problems
- Break1
- Contamination /Decontamination Problem1
- Naturally Worn1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 29, 2022Break; Break
IT WAS REPORTED ONE OF THE BOXES OF TC3 WAS ALL BROKEN AND WHEN THE PATIENT WAS ALREADY ANESTHETIZED IT PIERCED THE CLOTHS THAT PROTECT IT FOR STERILIZATION HAVING BECOME INFECTED AND COMPROMISED THE SURGERY. SURGERY HAS BEEN CANCELED.
Patient problems: Insufficient Information
MAUDE report 16073037 ↗MalfunctionNov 10, 2022Contamination /Decontamination Problem; Naturally Worn; Contamination /Decontamination Problem; Naturally Worn
IT WAS REPORTED THE TRAY IS WORN AND EDGES ARE SHARP AND CAN¿T BE USED DUE TO NOT BEING ABLE TO STERILIZE APPROPRIATELY IN STERILE WRAPPING. NO ADVERSE AFFECTS ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15774947 ↗
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.
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