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HOFFMANN 4934-6-140Recalls & reported problems

Stryker GmbH · Foot Arch LRF · Class 2

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 07613252611479), received between Jun 7, 2019 and Jun 7, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Detachment of Device or Device Component1
  • Device Slipped1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 7, 2019Device Slipped; Detachment of Device or Device Component

    IT WAS REPORTED THAT A KIT HAD FOOT ARCHES THAT WERE "FAULTY"; THE BONDING ON THE POSTS ARE LOOSE AND DETACH FROM THE CARBON ARCH. NO ASSOCIATED PROCEDURE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8680858 ↗

Other APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT devices

All APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT devices →

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