Arthrex® AR-2653CLSRecalls & reported problems
Arthrex, Inc. · CLAV FRAC PLT,CENTRAL THIRD,LFT,SS, STRL · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867195929), received between Dec 13, 2021 and Jul 15, 2025 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Break” (3 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break3
Patient problems
- Insufficient Information2
- Failure of Implant1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJul 15, 2025Break; Break
IT WAS REPORTED THAT THE PLATE BROKE POST OPERATIVE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 AND A NEW PLATE WITH THE SAME PART NUMBER WAS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 22509587 ↗MalfunctionDec 5, 2022Break
IT WAS REPORTED THAT A FEW WEEKS AFTER THE SURGERY THE CLAVICULA PLATE BROKE IN TWO PARTS IN THE PATIENT. UPDATE 17-NOV-2022: THE INITIAL SURGERY TOOK PLACE ON (B)(6) 2022, THE BREAKAGE OF THE PLATE WAS NOTICED ON (B)(6) 2022 AND TREATED ON (B)(6) 2022. THE REVISION SURGERY WAS PERFORMED WITH TWO CLAVICLE PLATES AND CANCELLOUS BONE.
Patient problems: Insufficient Information
MAUDE report 15914093 ↗MalfunctionDec 13, 2021Break
IT WAS REPORTED THAT A REVISION CLAVICLE SURGERY WAS PERFORMED ON THE (B)(6) 2021 DUE TO A BREAKAGE OF THE DEVICE 11 WEEKS AFTER THE INITIAL SURGERY. THE INITIAL SURGERY TOOK PLACE ON THE (B)(6) 2021. THE BREAKAGE OCCURRED WITH PARTIAL LOADING, WITHOUT TRAUMA AND IMPROPER TREATMENT. THERE WAS NO EVIDENCE FOR AN INFECTION. THE REVISION SURGERY WAS FINISHED SUCCESSFULLY AND NO BROKEN PARTS REMAINED INSIDE THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 12984740 ↗
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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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