STERNALOCK® BLU SYSTEM 73-2412 (UDI 00888233000888)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888233000888), received between Sep 2, 2020 and Aug 15, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K110574, K121302, K161896); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 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 22815002 ↗
• 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 22814997 ↗
• InjurySep 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A REVISION DUE TO BLEEDING ONE (1) DAY FOLLOWING CLOSURE WITH STERNAL PLATES AND SCREWS. IT WAS REPORTED THE SURGEON DID NOT USE THE PLATE CONFIGURATION RECOMMENDED BY THE IFU IN THE ORIGINAL IMPLANTATION SURGERY. ONE (1) OUT OF THE ORIGINAL THREE (3) PLATES WERE REPLACED IN THE REVISION. IT WAS REPORTED THAT NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10483885 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K110574, K121302, K161896. One submission often covers many models, so check the product and lot details in each record.

• Z-0843-2012 · Nov 23, 2011 · Terminated
  The SternaLock Blu Implant Tray includes plates, screws, screw measuring device, and blades. The SternaLock Blu Implant Tray would have been found within the following outer cont