Arthrex® AR-16001400Recalls & reported problems
Arthrex, Inc. · REPL PRT AR-1600M LAT TRACTION HUB ASSY · Class 1
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 00888867237209), received between Jun 9, 2024 and Jun 9, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Connection 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.
Reports received per month
Most reported problems
Device problems
- Connection Problem1
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, 2024Connection Problem; Connection Problem
ON 3/2/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-1600MLIMB POSITIONER IS NOT LOCKING, THEY BELIEVE A SCREW MAY HAVE BEEN STRIPPED. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19495241 ↗
Other Apparatus, traction, non-powered devices
- Arthrex® AR-1600MArthrex, Inc. · Apparatus, traction, non-powered21 reports
- Active Heel Traction Boot 72203270Smith & Nephew, Inc. · APPARATUS, TRACTION, NON-POWERED20 reports
- NA 357.371Synthes GmbH · APPARATUS, TRACTION, NON-POWERED16 reports
- NA SD393.640Synthes GmbH · APPARATUS, TRACTION, NON-POWERED15 reports
- NA 394.44Synthes GmbH · APPARATUS, TRACTION, NON-POWERED12 reports
- Active Heel Traction Boot 72202682Smith & Nephew, Inc. · APPARATUS, TRACTION, NON-POWERED10 reports
- Arthrex® AR-8970JDArthrex, Inc. · Apparatus, traction, non-powered10 reports
- NA 72201725Smith & Nephew, Inc. · APPARATUS, TRACTION, NON-POWERED8 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.
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