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CHS 110020Recalls & reported problems

Smith & Nephew, Inc. · PLATE TAMPER AMBI/RICHARDS CLASSIC · Class 1

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 03596010033161), received between Nov 3, 2021 and Nov 3, 2021 — 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break2
  • Naturally Worn2

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.

  • MalfunctionNov 3, 2021Break; Naturally Worn; Break; Naturally Worn

    IT WAS REPORTED THAT THE PLATE TAMPER (AMBI/RC) WAS NOTICED TO HAVE THE TIP CHIPPED DUE TO NORMAL WEAR AND TEAR. AS THIS WAS NOTICED UPON MEDICAL DEVICE PROCESSING, THERE WAS NO CASE OR PATIENT INVOLVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12746228 ↗
  • MalfunctionNov 3, 2021Break; Naturally Worn; Break; Naturally Worn

    IT WAS REPORTED THAT THE PLATE TAMPER (AMBI/RC) WAS NOTICED TO HAVE THE TIPS CHIPPED DUE TO NORMAL WEAR AND TEAR. AS THIS WAS NOTICED UPON MEDICAL DEVICE PROCESSING, THERE WAS NO CASE OR PATIENT INVOLVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12746159 ↗

Other TAMP devices

All TAMP devices →

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