2.0 LACTOSORB SYSTEM 915-2101Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00841036054397), received between Dec 6, 2019 and Jun 22, 2026 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 22, 2026Contamination /Decontamination Problem

  IT WAS REPORTED DURING INSPECTION AT THE DISTRIBUTORSHIP, A HAIR-LIKE SUBSTANCE WAS FOUND WITHIN THE STERILE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25587421 ↗
• InjuryDec 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Swelling/ Edema

  MAUDE report 13013741 ↗
• InjuryDec 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INFECTION AND INFLAMMATION WERE DISCOVERED NINE (9) DAYS FOLLOWING IMPLANTATION OF PLATES AND SCREWS AND A REMOVAL WAS PLANNED TWO (2) WEEKS FOLLOWING IMPLANTATION. THE SURGEON IS UNCERTAIN AS TO THE CAUSE OF THE INFECTION AND THINKS IT IS POSSIBLE THAT THE PLATES AND SCREWS ARE THE CAUSE OF THE INFECTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 11086849 ↗
• InjuryDec 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: Wound Dehiscence

  MAUDE report 9428703 ↗

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