STERNALOCK® BLU SYSTEM 73-2643 (UDI 00888233000987)Recalls & reported problems
Biomet Microfixation, Inc · Class 2 · Implant
All models of STERNALOCK BLU SYSTEM (31)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888233000987), received between Sep 2, 2020 and Aug 15, 2025 — classified as 4 injuries.
The most frequently reported specific device problem is “Migration” (2 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, 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Migration2
- Adverse Event Without Identified Device or Use Problem1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Bacterial Infection2
- Aseptic loosening1
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryAug 15, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT A PATIENT IS SCHEDULED TO UNDERGO A REVISION PROCEDURE APPROXIMATELY 3 MONTHS POST IMPLANTATION DUE TO A LOOSENED SCREW/PLATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Aseptic loosening
MAUDE report 22815003 ↗InjuryJul 1, 2021Migration; Migration
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Bacterial Infection
MAUDE report 12099269 ↗InjuryJul 1, 2021Migration; Migration
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Bacterial Infection
MAUDE report 12099268 ↗InjurySep 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 10483858 ↗
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- PRECICE® Plating System LP4.5-MRT4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls3 reports
- PRECICE® Plating System LP4.5-DRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls1 report
- PRECICE® Plating System LP4.5-PLF40Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
- PRECICE® Plating System LP4.5-PRT42Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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