Arthrex AR-6529-05LRecalls & reported problems
Allen Medical Systems, Inc. · HDS Long Operative Leg Spar · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00615521004736), received between Nov 28, 2025 and Dec 9, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Unintended Movement” (2 reports).
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
- Unintended Movement2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 9, 2025Unintended Movement; Unintended Movement
BAXTER RECEIVED A REPORT STATING THAT STABILIZER LEG HDS HAD STABILIZER LEG MISSING SCREWS AND CAUSED DEVICE TO FALL OUT. NO HARM OR SIGNIFICANT IMPACT TO THE SURGICAL PROCEDURE WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23763743 ↗MalfunctionNov 28, 2025Unintended Movement; Unintended Movement
BAXTER RECEIVED A REPORT STATING THAT HDS LONG OPERATIVE LEG SPAR WAS NOT HOLDING THE WEIGHT. NO HARM OR SIGNIFICANT IMPACT TO THE SURGICAL PROCEDURE WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23671875 ↗
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- NA 394.44Synthes GmbH · APPARATUS, TRACTION, NON-POWERED12 reports
- Arthrex® AR-8970JDArthrex, Inc. · Apparatus, traction, non-powered10 reports
- Active Heel Traction Boot 72202682Smith & Nephew, 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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