1.5 LACTOSORB SYSTEM 915-2316Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00841036055196), received between Apr 6, 2021 and Nov 29, 2023 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 reports).

4 other recalls cover devices cleared under the same FDA submission (K002083, 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 29, 2023Manufacturing, Packaging or Shipping Problem; Packaging Problem; Manufacturing, Packaging or Shipping Problem; Packaging Problem

  IT WAS REPORTED THAT THE DISTRIBUTORSHIP FOUND DEBRIS WITHIN THE STERILE PACKAGING. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18227591 ↗
• MalfunctionNov 29, 2023Manufacturing, Packaging or Shipping Problem; Packaging Problem; Manufacturing, Packaging or Shipping 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 18227584 ↗
• MalfunctionOct 10, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT WHEN THE PACKAGING WAS OPENED, IT CONTAINED A HAIR OR THREAD. ANOTHER PRODUCT WAS USED TO COMPLETE THE SURGERY. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15569503 ↗
• MalfunctionApr 6, 2021Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11624599 ↗
• MalfunctionApr 6, 2021Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11624589 ↗
• MalfunctionApr 6, 2021Fracture; Fracture

  IT WAS REPORTED THAT SIX (6) SCREWS FRACTURED UPON IMPLANTATION. THE SCREWS WERE USED ON THE INFRAORBITAL MARGIN AND ZYGOMATIC FRONTAL SUTURE. THE SURGEON THOUGHT HE WAS NOT INSERTING THE SCREW DIAGONALLY BECAUSE IT WAS THE LOWER EDGE AND THE SUTURE. THE SURGEON ALSO THOUGHT IT WAS STRANGE THAT THE EVENT OCCURRED EVEN IF THE PATIENT¿S BONES WERE HARD. THE MALFUNCTIONS CAUSED A DELAY GREATER THAN THIRTY (30) MINUTES. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11624530 ↗
• MalfunctionApr 6, 2021Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11624521 ↗
• MalfunctionApr 6, 2021Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11624491 ↗
• MalfunctionApr 6, 2021Fracture; Fracture

  IT WAS REPORTED THAT SIX (6) SCREWS FRACTURED UPON IMPLANTATION. THE SCREWS WERE USED ON THE INFRAORBITAL MARGIN AND ZYGOMATIC FRONTAL SUTURE. THE SURGEON THOUGHT HE WAS NOT INSERTING THE SCREW DIAGONALLY BECAUSE IT WAS THE LOWER EDGE AND THE SUTURE. THE SURGEON ALSO THOUGHT IT WAS STRANGE THAT THE EVENT OCCURRED EVEN IF THE PATIENT¿S BONES WERE HARD. THE MALFUNCTIONS CAUSED A DELAY GREATER THAN THIRTY (30) MINUTES. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11624479 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K002083, 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
• Z-0384-2012 · Feb 17, 2006 · Terminated
  Product is 65mm Flexible Tube***NON-STERILE PRODUCT***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN." W.LORENZ SURGICAL***WALTER LORENZ SURG
• Z-0385-2012 · Feb 17, 2006 · Terminated
  Product is 35mm Flex Tube***NON-STERILE PRODUCT***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN." W.LORENZ SURGICAL***WALTER LORENZ SURGICAL
• Z-0383-2012 · Feb 17, 2006 · Terminated
  Product is 40mm Flexible Tube. ***NON-STERILE PRODUCT***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN." W.LORENZ SURGICAL***WALTER LORENZ S