Compress® Device 178366Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00880304509047), received between Mar 31, 2021 and Aug 12, 2025 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (3 reports).

1 FDA recall record name this device's identifier.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Aug 21, 2019Terminated

   Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.

   Z-0519-2020 · Root cause: Environmental control · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryAug 12, 2025Fracture; Fracture

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

  Patient problems: Bone Fracture(s); Failure of Implant

  MAUDE report 22781280 ↗
• MalfunctionFeb 6, 2025Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21326987 ↗
• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS BEING CONSIDERED FOR A RIGHT KNEE ARTHROPLASTY REVISION TO ADDRESS FLEXION CONTRACTURE AND STIFFNESS APPROXIMATELY TWENTY-TWO (22) MONTHS FOLLOWING KNEE ARTHROPLASTY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information; Joint Contracture; Loss of Range of Motion

  MAUDE report 21036165 ↗
• InjuryAug 28, 2024Adverse 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: Failure of Implant

  MAUDE report 20085013 ↗
• InjuryDec 31, 2021Fracture; Fracture

  UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 13124963 ↗
• InjuryMar 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS DEVICE IS NOT BELIEVED TO HAVE CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: Bone Fracture(s)

  MAUDE report 11598568 ↗