Arthrex® AR-13200T-12.5Recalls & reported problems
Arthrex, Inc. · PLT,OPENG WEDG OSTEO · Class 2 · Implant
Data updated Oct 18, 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 00888867009752), received between Jul 3, 2023 and Jul 3, 2023 — classified as 1 injury.
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 18, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 3, 2023Break; Break
ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (2) AR-13380-42 CORTICAL SCREWS WERE FOUND BROKEN DURING A POST-OPERATIVE FOLLOW-UP. THE PROCEDURE WAS A HIGH TIBIAL OSTEOTOMY. THE PATIENT DID NOT HAVE ANY SIGNIFICANT COMPLAINTS AND DID NOT RECALL AN EVENT OR INJURY TO HAVE OCCURRED. A COLLAPSE WAS NOTICED IN THE PATIENT'S OSTEOTOMY SITE. THE IMPLANTS ARE STILL IN THE PATIENT, AND REVISION SURGERY HAS NOT HAPPENED YET. ADDITIONAL INFORMATION RECEIVED ON 6/8/2023: THE ORIGINAL PROCEDURE OCCURRED ON (B)(6) 2023, AND REVISION SURGERY OCCURRED ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON 6/16/2023: DURING THE REVISION SURGERY, AN AR-13200T-12.5 TIBIAL OPENING WEDGE OSTEOTOMY PLATE, TWO AR-13280-45 CANCELLOUS SCREW, AND THREE AR-13370-3 OSFERION OSTEOTOMY WEDGE WERE EXPLANTED ALONG WITH THE TWO BROKEN AR-13380-42 CORTICAL SCREWS. BOTH SURGERIES WERE PERFORMED AT THE SAME FACILITY AND BY THE SAME SURGEON.
Patient problems: Failure of Implant
MAUDE report 17246916 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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