ACUFEX 7207284Recalls & reported problems
Smith & Nephew, Inc. · PCL SAFETY GUIDE WIRE REQUIRED CALIBRATED GUIDE WIRE USED IN CONJUNCTION WITH THE ACUFEX DIRECTOR PCL SAFETY STOP TO INDICATE WHEN THE TIP OF THE WIRE HAS PENETRATED THE POSTERIOR CORTEX · Class 1
All models of ACUFEX (86)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010388254), received between May 18, 2026 and May 18, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 18, 2026Fracture
IT WAS REPORTED THAT, AFTER A PCL RECONSTRUCTION PROCEDURE, WHILE AN X-RAY WAS DONE, IT WAS NOTICED THAT, DURING THE SURGERY, WHEN ONE (1) GUIDE WIRE WAS INSERTED INTO THE TIBIA, THE DISTAL TIP WAS FRACTURED AND REMAINED EMBEDDED WITHIN THE BONE. THE PIECE WAS LEFT IN THE PATIENT. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.
Patient problems: Foreign Body In Patient
MAUDE report 25202331 ↗
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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 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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