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Gluteal Implant, Round, Textured, SDM Size: 18.0cm x 14.0cm x 4.5cmRecalls & reported problems

Implantech Associates, Inc. · Gluteal Implant · Class 2 · Implant

Data updated Oct 18, 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 M724CCB6T841), received between Jan 25, 2018 and Jan 25, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Device Damaged Prior to Use1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionJan 25, 2018Device Damaged Prior to Use; Device Damaged Prior to Use

    COMPLAINANT REPORTED THAT THEY RECEIVED A GLUTEAL IMPLANT THAT CONTAINED BUBBLES. THEY PROCEEDED TO INSERT THE IMPLANT INTO A KELLER FUNNEL, AND IT RIPPED. THE PROBLEM OCCURRED BEFORE THERE WAS ANY PATIENT CONTACT, AND THEY HAD A BACKUP AVAILABLE SO THERE WAS NO IMPACT TO THE PATIENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7219175 ↗

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Sources and updates

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