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HXBClass 1

Probe

FDA adverse event reports and recall history for probe (product code HXB), from the public MAUDE/AEMS corpus and the live FDA recall database.

Total reports
595
Deaths
0
Injuries
84
Malfunctions
503

Reports per year

12
13
14
15
16
17
18
19
20
21
22
23
24
25
26

Source: FDA adverse event reports by year received, 20122026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

  • 2025-01-16Open, ClassifiedUnder Investigation by firm

    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE PROBE W/EYE CS/50, Model Number 94-5923; 2) ECONO STERIL" PROBE W/EYE 5.5" STERL CS/25, Model Number 96-2361; orthopedic probe

    Reports of various packaging issues that may result in a breach of the sterile barrier.

  • 2014-12-23TerminatedDevice Design

    NexGen Complete Knee Solution Monoblock Tibial Provisional / Drill Guide Tibial Size 5 Femoral Size Green / CH Zimmer U.K. Ltd., SN3 4FP, UK Zimmer Trabecular Metal Technology, Inc 10 Pomeroy Road, Parsippany, NJ 07054 USA

    During cleaning, two separate units of the NexGen Tibial Base plates did not fit with the Tibial Base Plate handle.

  • 2014-01-03TerminatedProcess change control

    PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation.

    Bone Probes used to create a pathway in pedicle bone were manufactured and marked to incorrect specifications.

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