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NA 5983-92Recalls & reported problems

Zimmer, Inc. · Class 1

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

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024218802), received between Jun 25, 2020 and Oct 20, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (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

  • Fracture3

Patient problems

  • No Clinical Signs, Symptoms or Conditions2
  • No Patient Involvement1

Recent adverse event reports

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

  • MalfunctionOct 20, 2021Fracture; Fracture

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12669039 ↗
  • MalfunctionJul 12, 2021Fracture; Fracture

    THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12149409 ↗
  • MalfunctionJun 25, 2020Fracture; Fracture

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Patient problems: No Patient Involvement

    MAUDE report 10194472 ↗

Other IMPACTOR devices

All IMPACTOR devices →

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