Natrelle INSPIRA Resterilizable Sizers MSZ-X285Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888628009462), received between Jun 21, 2023 and Jun 21, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Material Rupture” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K831566); they may or may not involve this specific model.

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

Recent adverse event reports

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

• InjuryJun 21, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE EXCHANGE DUE TO CONCERNS WITH THE PRODUCT. LATER, HEALTHCARE PROFESSIONAL REPORTED PAIN, LUMP/NODULE, CAPSULAR CONTRACTURE BAKER GRADE II, AND RUPTURE AGAINST THE DEVICE. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant; Necrosis

  MAUDE report 17175196 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K831566. One submission often covers many models, so check the product and lot details in each record.

• Z-0702-2020 · Nov 6, 2019 · Terminated
  NATRELLE Resterilizable Sizers for the styles and sizes: Style 15, Style 20, Inspira X (responsive gel), Inspira F (responsive gel), Inspira LP (responsive gel), Inspira M (respons
• Z-1988-2015 · Jun 8, 2015 · Terminated
  Natrelle Re-sterilizable Breast Implant Sizer, Size: 410 cc, Style No. MSZFX410. The product is packaged in a thermoformed tray (double sterile barrier) and enclosed in a labeled