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ACS CDMH06FRecalls & reported problems

American Contract Systems, Inc. · ANTERIOR HIP PACK · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

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 00191072055149), received between Aug 1, 2019 and Aug 1, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Contamination of Device Ingredient or Reagent” (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

  • Contamination of Device Ingredient or Reagent1

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.

  • MalfunctionAug 1, 2019Contamination of Device Ingredient or Reagent

    HAIR FOUND IN ANTERIOR HIP PACK. TABLES CONTAMINATED AND ALL TORN DOWN; PATIENT WAS IN THE OPERATING ROOM. SMALL HAIR WAS FOUND IN OPENING FLAPS OF UNOPENED SUTURE, #1 ETHIBOND X538, WITHIN THE PACK.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8850686 ↗

Other General surgery tray devices

All General surgery tray devices →

Sources and updates

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