Arthrex® AR-2651CRRecalls & reported problems
Arthrex, Inc. · CLAV FRAC PLT,CENTRAL THIRD,RT,SS · 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 00888867027411), received between Dec 2, 2016 and Dec 2, 2016 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 2, 2016Fracture
IT WAS REPORTED THAT ON (B)(6) 2016, THE PATIENT UNDERWENT AN ORIF RIGHT CLAVICLE PROCEDURE. THE AR-2651CR- RIGHT CENTRAL THIRD CLAVICLE FRACTURE PLATE (LOT: 6791245, (B)(4)) THAT WAS IMPLANTED, BROKE INTO 2 PIECES AT THE MIDDLE HOLES, 4 WEEKS POST-OP. NONE OF THE SCREWS HAD BROKEN. THE PATIENT HAD A REVISION SURGERY ON (B)(6) 2016 TO REMOVE THE BROKEN AR-2651CR - RIGHT CENTRAL THIRD CLAVICLE FRACTURE PLATE (LOT: 6791245, (B)(4)) AND THE FOLLOWING SCREWS: AR-8835-12 - LO-PRO SCREW (LOT: 95241530, (B)(4)), AR-8835-14 - LO-PRO SCREW (LOT: AMD062302, (B)(4)), AR-8835-16 - LO-PRO SCREW (LOT: 1532108, (B)(4)), AR-8835L-12 - LO-PRO LOCK SCREW (LOT: D64603, (B)(4)), AR-8835L-16 - LO-PRO LOCK SCREW (LOT: 1149265- QTY: 3, (B)(4)) AND, AN AR-8835L-18- LO-PRO LOCK SCREW (LOT: 1288269, (B)(4)) AND REPLACE IT WITH AN AR-2652CR - RIGHT CENTRAL THIRD CLAVICLE FRACTURE PLATE (LOT: 6791448) AND SCREWS. PATIENT IS A (B)(6) MALE. NO PATIENT HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6141220 ↗
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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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