1.5 LACTOSORB SYSTEM 915-2419Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841036055554), received between Dec 13, 2021 and Jan 5, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (1 report).

1 other recall cover devices cleared under the same FDA submission (K955729, K971870); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING NEUROSURGERY, NOTICEABLE INDENTATIONS AND YELLOW FOREIGN MATERIAL WERE FOUND ON THE INNER STERILE PACKAGING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23957606 ↗
• MalfunctionDec 13, 2021Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE NURSE NOTICED WHILE AT THE BACK TABLE THAT THE PLATE PACKAGING DID NOT MEET THE STERILE REQUIREMENTS. A LIKE ITEM WAS USED TO COMPLETE THE PROCEDURE WITH NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12982997 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K955729, K971870. One submission often covers many models, so check the product and lot details in each record.

• Z-1872-2008 · Mar 19, 2008 · Terminated
  Lactosorb Trauma Plating System, part numbers: 915-2100, 915-2423, 915-2113, 915-2810, 915-2418, 915-2105, 915-2832 and CP-1323. The system is used in trauma and reconstructive su