MP Reconstruction Prosthesis 99-0984/32Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04026575409785), received between Nov 26, 2024 and Nov 26, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Inaccurate Information” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K142187); 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Dec 5, 2024Open, Classified

   Error on the main label and the patient label. The labels indicate a size XXL, this is a standard-size neck segment.. All further information on the labels is correct (Length, CCD and Offset).

   Z-0769-2025 · Root cause: Under Investigation by firm · FDA record ↗

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.

• MalfunctionNov 26, 2024Inaccurate Information; Inaccurate Information

  THE LABELS (MAIN LABEL AS WELL AS PATIENT LABEL) INDICATE A SIZE XXL, ALTHOUGH THIS IS A STANDARD-SIZE NECK SEGMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20785194 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K142187. One submission often covers many models, so check the product and lot details in each record.

• Z-0733-2019 · Dec 7, 2018 · Terminated
  LINK STEM with Microporous Surface MP Reconstruction Prosthesis, CEMENTLESS (Size XS-0, D: 12mm, L: 160mm), Reference Number 172-916/12 Product Usage: The LINK STEM with Microporo