LACTOSORB SYSTEM 915-2822 (UDI 00841036195328)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841036195328), received between Feb 28, 2020 and Feb 28, 2020 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K980927); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WILL UNDERGO A RE-OPERATION. THE PATIENT WAS EXPERIENCING ENOPHTHALMOS AND DIPLOPIA FOLLOWING AN ORBITAL FLOOR FRACTURE AND WAS IMPLANTED WITH AN ORBITAL PLATE. APPROXIMATELY SIX MONTHS AFTER THE OPERATION, THE PATIENT'S SYMPTOMS RETURNED AND A RE-OPERATION IS PLANNED. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Bone Fracture(s)

  MAUDE report 9772298 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K980927. 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