2.0 LACTOSORB SYSTEM 915-2102Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00841036054410), received between May 24, 2021 and Dec 15, 2021 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Packaging 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.

• InjuryDec 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED SWELLING APPROXIMATELY 8 MONTHS AFTER A PIRIFORM APERTURE WITH LACTOSORB FOR MAXILLARY OSTEOTOMY. THE PATIENT HAS INDICATED FOR A REVISION, ALTHOUGH IT HAS YET TO OCCUR. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Swelling/ Edema

  MAUDE report 13013637 ↗
• 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 12540562 ↗
• InjuryMay 24, 2021Adverse 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: Bacterial Infection; Purulent Discharge; Swelling/ Edema

  MAUDE report 11872445 ↗
• InjuryMay 24, 2021Adverse 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: Bacterial Infection; Purulent Discharge; Swelling/ Edema

  MAUDE report 11872435 ↗

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