1.5 LACTOSORB SYSTEMRecalls & reported problems across all models
Biomet Microfixation, Inc · 11 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 27
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls
- 0
We found 11 models of 1.5 LACTOSORB SYSTEM by Biomet Microfixation, Inc in the FDA's device registry (GUDID). Together they are named in 27 adverse event reports in the FDA's MAUDE database, received between May 16, 2019 and Jun 26, 2026 — classified as 7 injuries, 20 malfunctions.
The most frequently reported specific device problem is “Fracture” (8 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported 1.5 LACTOSORB SYSTEM problems
Device problems
- Fracture8
- Packaging Problem5
- Adverse Event Without Identified Device or Use Problem4
- Manufacturing, Packaging or Shipping Problem4
- Patient-Device Incompatibility4
- Expulsion2
- Contamination /Decontamination Problem1
- Device Contaminated During Manufacture or Shipping1
Patient problems
- No Clinical Signs, Symptoms or Conditions19
- Bacterial Infection4
- Unspecified Infection4
- Inflammation2
- No Known Impact Or Consequence To Patient1
- Reaction1
1.5 LACTOSORB SYSTEM models
11 models, most reported first. Each model has its own page with its reports, recalls and device details.
- 1.5 LACTOSORB SYSTEM 915-2316PLATE, FIXATION, BONE9 reports
- 1.5 LACTOSORB SYSTEM 915-2315POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE3 reports
- 1.5 LACTOSORB SYSTEM 915-2314PLATE, FIXATION, BONE2 reports
- 1.5 LACTOSORB SYSTEM 915-2413Screw, fixation, bone2 reports
- 1.5 LACTOSORB SYSTEM 915-2414Screw, fixation, bone2 reports
- 1.5 LACTOSORB SYSTEM 915-2419Screw, fixation, bone2 reports
- 1.5 LACTOSORB SYSTEM 915-2422Screw, fixation, bone2 reports
- 1.5 LACTOSORB SYSTEM 915-2427PLATE, FIXATION, BONE2 reports
- 1.5 LACTOSORB SYSTEM 915-2417PLATE, FIXATION, BONE1 report
- 1.5 LACTOSORB SYSTEM 915-2423PLATE, FIXATION, BONE1 report
- 1.5 LACTOSORB SYSTEM 915-2316-EAPLATE, FIXATION, BONE1 report
Recent 1.5 LACTOSORB SYSTEM adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 26, 2026Contamination /Decontamination Problem
IT WAS REPORTED DURING INSPECTION OF THE PRODUCT 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 25636290 ↗MalfunctionJan 5, 2026Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT DURING NEUROSURGERY, NOTICEABLE INDENTATIONS AND YELLOW FOREIGN MATERIAL WERE FOUND ON THE INNER STERILE PACKAGING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23957606 ↗MalfunctionAug 19, 2025Fracture; Fracture
ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22842510 ↗MalfunctionDec 23, 2024Patient-Device Incompatibility; Patient-Device Incompatibility
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21000240 ↗MalfunctionDec 23, 2024Patient-Device Incompatibility; Patient-Device Incompatibility
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21000238 ↗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 ↗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 ↗MalfunctionJul 31, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17426744 ↗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 ↗MalfunctionDec 13, 2021Packaging Problem; Packaging Problem
IT WAS REPORTED THAT DURING THE PROCEDURE, THE NURSE NOTICED WHILE AT THE BACK TABLE THAT THE PLATE PACKAGING DID NOT MEET THE STERILE REQUIREMENTS. A LIKE ITEM WAS USED TO COMPLETE THE PROCEDURE WITH NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12982997 ↗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 12540559 ↗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 ↗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 ↗
Other Biomet Microfixation, Inc products
- TMJ SYSTEM36 models · 458 reports
- "1.5MM" SYSTEM35 models · 224 reports
- STERNALOCK BLU SYSTEM31 models · 122 reports
- 2.0 LACTOSORB SYSTEM16 models · 110 reports
- TRAUMAONE SYSTEM39 models · 80 reports
- 2.4MM SYSTEM7 models · 70 reports
- RIBFIX BLU SYSTEM19 models · 56 reports
- PECTUS SYSTEM35 models · 55 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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