1.5 LACTOSORB SYSTEM 915-2315Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841036055189), received between Apr 2, 2021 and Dec 23, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Packaging Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K012409, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 23, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT IS REPORTED THAT THE SCREW WAS LOOSE IN ITS FIXATION DURING IMPLANTATION, SO ANOTHER PRODUCT WAS USED TO COMPLETE THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21000236 ↗
• MalfunctionSep 28, 2021Packaging Problem; Packaging Problem

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12540500 ↗
• InjuryApr 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE DEVICES WERE REMOVED DUE TO INFECTION. THE DEVICES WERE USED TO CLOSE A CRANIOTOMY IN A PEDIATRIC CASE. THE PATIENT COMPLAINED OF PUS AT THE PLATE FIXATION SITE AND THE PLATE WAS REMOVED AT A LATER DATE. THE SAME SYMPTOM OCCURRED SEVERAL WEEKS AGO, AND THE PLATE HAS ALREADY BEEN REMOVED. THIS COMPLAINT OCCURRED IN THE REMAINING TWO PLACES WITH THREE FIXED POINTS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bacterial Infection; Inflammation

  MAUDE report 11609372 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K012409, 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