CARDINAL HEALTH SOP12KNM10Recalls & reported problems
Cardinal Health 200, LLC · TOTAL KNEE PACK · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10197106928387), received between Jun 9, 2025 and Jun 9, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (1 report).
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Tear, Rip or Hole in Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 9, 2025Tear, Rip or Hole in Device Packaging
HOLE NOTED ON THE INSIDE OF STERILE PACK PRIOR TO OPENING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22166854 ↗
Other Orthopedic tray devices
- Medline Industries, Inc. DYNJ900718CMedline Industries, Inc. · Orthopedic tray5 recalls0 reports
- Medline Industries, Inc. DYNJ905330BMedline Industries, Inc. · Orthopedic tray5 recalls0 reports
- Medline Industries, Inc. DYNJ17452SMedline Industries, Inc. · Orthopedic tray5 recalls0 reports
- Medline Industries, Inc. DYNJ21826RMedline Industries, Inc. · Orthopedic tray5 recalls0 reports
- Medline Industries, Inc. CDS780119VMedline Industries, Inc. · Orthopedic tray5 recalls0 reports
- Medline Industries, Inc. DYNJ902473LMedline Industries, Inc. · Orthopedic tray5 recalls0 reports
- Medline Industries, Inc. DYNJ906893DMedline Industries, Inc. · Orthopedic tray4 recalls2 reports
- Medline Industries, Inc. DYNJ909505AMedline Industries, Inc. · Orthopedic tray4 recalls1 report
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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