Arthrex® AR-8006SRecalls & reported problems
Arthrex, Inc. · DOUBLE COMPRESSION PLATE SET · 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 00888867121799), received between Apr 7, 2026 and Apr 7, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 7, 2026Break
ON 12-MAR-2026, ARTHREX WAS NOTIFIED VIA EMAIL OF A CASE STUDY PUBLISHED IN 2021 BY FOOT & ANKLE ORTHOPAEDICS, TITLED ¿RADIOGRAPHIC OUTCOMES, UNION RATES, AND COMPLICATIONS ASSOCIATED WITH PLANTAR IMPLANT POSITIONING FOR MIDFOOT ARTHRODESIS". THE STUDY REVIEWED THIRTY-FOUR (34) PATIENTS WHO UNDERWENT MIDFOOT ARTHRODESIS, USING AR-8006S ¿ DOUBLE COMPRESSION PLATE SET. DURING THE SIXTEEN TO SIXTY-SIX (16-66) MONTH FOLLOW-UP PERIOD, FOUR (4) PATIENTS EXPERIENCED PLATE BREAKAGE WITHOUT NONUNION. SOURCE: FRASER TW, MILES DT, HUANG N, DAVIS FB, DUNLAP BD, DOTY JF. RADIOGRAPHIC OUTCOMES, UNION RATES, AND COMPLICATIONS ASSOCIATED WITH PLANTAR IMPLANT POSITIONING FOR MIDFOOT ARTHRODESIS. FOOT & ANKLE ORTHOPAEDICS. 2021/07/01 2021;6(3):24730114211027115. DOI:10.1177/24730114211027115.
Patient problems: Insufficient Information
MAUDE report 24800217 ↗
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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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