Compress® Device 178362Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00880304508965), received between Dec 30, 2024 and Dec 30, 2024 — classified as 1 injury.
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.
Reports received per month
Recalls naming this device
- 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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Insufficient Information1
- Joint Contracture1
- Loss of Range of Motion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
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 21036156 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.