Compress® Device 178370Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00880304509139), received between Dec 2, 2024 and Mar 3, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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
- Detachment of Device or Device Component1
- Fracture1
Patient problems
- Failure of Implant1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 3, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT APPROXIMATELY 9 MONTHS POST IMPLANTATION OF A COMPRESS SYSTEM, THE PATIENT EXPERIENCED SUDDEN ONSET PAIN. X-RAYS REVEALED THAT THE ANCHOR PLUG HAD FRACTURED AND SPINDLE DISASSEMBLED. SUBSEQUENTLY, THE PATIENT WAS REVISED OF THE COMPRESS SYSTEM WITH A NEW COMPRESS SYSTEM. IT IS NOTED BY THE REPORTING HEALTHCARE PROFESSIONAL THAT THE PATIENT DOES HAVE A HIGH BMI THAT MAY HAVE BEEN A CONTRIBUTING CAUSE TO THE EVENT. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.
Patient problems: Pain
MAUDE report 24503169 ↗InjuryDec 2, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 20825818 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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