Arthrex® AR-2655CRRecalls & reported problems
Arthrex, Inc. · CLAV FRAC PLT,CENTRAL THIRD,RT,SS · Class 2 · Implant
Data updated Oct 16, 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 00888867027497), received between Jun 29, 2017 and Jun 29, 2017 — 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 16, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- Bone Fracture(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 29, 2017Break
IT WAS REPORTED THAT THE PATIENT HAD A CLAVICLE FRACTURE SURGERY THAT WENT WELL AND PATIENT WAS DISCHARGED. WHEN THE PATIENT RETURNED FOR THE MEDICAL CHECK UP THE IMPLANTED PLATE WAS BROKEN. THE PATIENT STATED HE DID NOT FALL OR HAVE ANY TRAUMA TO CAUSE THE PLATE TO BREAK. A REVISION TOOK PLACE ON (B)(6) 2017 DURING WHICH THE BROKEN CLAVICLE PLATE AND ASSOCIATED SCREWS (PARTS/LOTS UNKNOWN) WERE EXPLANTED. IT WAS REPORTED THAT THIS IS NOW THE SECOND PLATE THAT BROKE ON THE SAME PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED SEVERAL TIMES WITH REGARD TO THE FIRST PLATE BREAKAGE INDICATED, BUT NO RESPONSE HAS BEEN RECEIVED AS OF 6/28/2017.
Patient problems: Bone Fracture(s)
MAUDE report 6676499 ↗
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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 13, 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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