ACUFEX 72205101Recalls & reported problems
Smith & Nephew, Inc. · ACUFEX ACCESS POSITIONING SYSTEM · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556715116), received between Jun 21, 2020 and Jun 21, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Positioning Problem” (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.
Most reported problems
Device problems
- Positioning Problem1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 21, 2020Positioning Problem; Positioning Problem
IT WAS REPORTED THAT THE ACUFEX POSITIONING SYSTEM WAS NOT HOLDING INTERNAL OR EXTERNAL ROTATION. NO CASE OR PATIENT INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Patient Involvement
MAUDE report 10177261 ↗
Other SUPPORT, PATIENT POSITION devices
- ALLEN 103001Hill-Rom, Inc. · SUPPORT, PATIENT POSITION1 recall17 reports
- DeRoyal 8000HDPDeroyal Industries, Inc. · SUPPORT, PATIENT POSITION16 reports
- PILLOW, GENTLETOUCH, 7 INCH RT 1937Mizuho Orthopedic Systems, Inc. · Support, Patient Position11 reports
- Battalion 27428Alphatec Spine, Inc. · SUPPORT, PATIENT POSITION3 reports
- Medline MSC50023Medline Industries, Inc. · SUPPORT, PATIENT POSITION2 reports
- Olympic Vac-Pac Size 30Natus Medical Incorporated · Support, Patient Position2 reports
- ACUFEX 72205103Smith & Nephew, Inc. · SUPPORT, PATIENT POSITION2 reports
- MEDLINE NON081147Medline Industries, Inc. · SUPPORT, PATIENT POSITION2 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page