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PROCARE 79-95725Recalls & reported problems

Djo, LLC · MAXTRAX 2.0, AIR, TALL, M · Class 1

Adverse event reports
3
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00190446665939), received between Sep 9, 2022 and Sep 9, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Insufficient Device Problem Information3

Patient problems

  • Unspecified Tissue Injury3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjurySep 9, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED THAT ALLEGEDLY 3 PATIENTS DEVELOPED SKIN BREAKDOWN NEEDING WOUND CARE WITH ONE NEEDING A SKIN GRAFT AND ONE BORDERLINE ANTERIOR TIBIAL TENDON EXPOSURE, THOUGH NOT INFECTED.

    Patient problems: Unspecified Tissue Injury

    MAUDE report 15396843 ↗
  • InjurySep 9, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED THAT ALLEGEDLY 3 PATIENTS DEVELOPED SKIN BREAKDOWN NEEDING WOUND CARE WITH ONE NEEDING A SKIN GRAFT AND ONE BORDERLINE ANTERIOR TIBIAL TENDON EXPOSURE, THOUGH NOT INFECTED.

    Patient problems: Unspecified Tissue Injury

    MAUDE report 15396763 ↗
  • InjurySep 9, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED THAT ALLEGEDLY 3 PATIENTS DEVELOPED SKIN BREAKDOWN NEEDING WOUND CARE WITH ONE NEEDING A SKIN GRAFT AND ONE BORDERLINE ANTERIOR TIBIAL TENDON EXPOSURE, THOUGH NOT INFECTED.

    Patient problems: Unspecified Tissue Injury

    MAUDE report 15396743 ↗

Other ORTHOSIS, CORRECTIVE SHOE devices

All ORTHOSIS, CORRECTIVE SHOE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.