Compress® Device 178363Recalls & 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 00880304508927), received between Feb 8, 2022 and Sep 9, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
- Migration1
Patient problems
- Ambulation or Postural Difficulties2
- Pain2
- Failure of Implant1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 9, 2025Migration; Migration
IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT COMPLAINED OF PAIN OVER A SPAN OF THE LAST YEAR. THE SURGEON BELIEVED THE EXPANDABLE COMPONENT WAS EXPANDING ON ITS OWN, WITHOUT THE REQUIRED SURGERY TO EXPAND IT. THE PATIENT FELT A POP AND COULD NOT BEAR WEAR. THE PATIENT WAS THEN REVISED APPROXIMATELY 3 YEARS POST IMPLANTATION DUE TO A BROKEN ANCHOR PLUG AND THE SPINDLE LOST BONE IN-GROWTH AT THE BONE INTERFACE AND WAS NO LONGER FIXED.
Patient problems: Ambulation or Postural Difficulties; Pain
MAUDE report 23010335 ↗InjuryFeb 8, 2022Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT HAD AN OSS COMPRESS IMPLANTED 7 MONTHS AGO. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO A BROKEN COMPRESS PART. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Pain
MAUDE report 13483106 ↗
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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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