STERNALOCK® BLU SYSTEM 73-2716Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841036143473), received between Dec 23, 2019 and Feb 10, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Deformation” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 10, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THE EIGHT SCREWS FRACTURED OR BENT DURING INSERTION FOR A STERNAL CLOSURE. THE FRACTURED SCREW FRAGMENTS REMAIN EMBEDDED IN THE PATIENT'S BONE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9690731 ↗
• InjuryDec 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED THAT INDICATED THE RE-OPERATION WAS PERFORMED DUE TO BLEEDING AND WAS NOT IN ANY WAY RELATED TO A DEVICE PROBLEM. THIS IS NOT A REPORTABLE EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 9513392 ↗

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