Arthrex® AR-2295Recalls & reported problems
Arthrex, Inc. · Two Incision Distal Biceps Implant Kit · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867307421), received between May 10, 2024 and Jul 30, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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
- Detachment of Device or Device Component2
- Break1
- Device Dislodged or Dislocated1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 30, 2026Device Dislodged or Dislocated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50081491 ↗MalfunctionDec 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ON 11/12/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT THE BUTTON FROM THE INSERTER OF AN AR-2295 TWO-INCISION DISTAL BICEPS IMPLANT SYSTEM REPEATEDLY FELL OFF WHILE LOADING OR IMPLANTING THE BUTTON. ANOTHER AR-2295 TWO-INCISION DISTAL BICEPS IMPLANT SYSTEM WAS OPENED, AND THE SAME ISSUE OCCURRED. THIS WAS DISCOVERED DURING A DISTAL BICEPS PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED ON 11/17/2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23707267 ↗MalfunctionDec 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ON 11/12/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT THE BUTTON FROM THE INSERTER OF AN AR-2295 TWO-INCISION DISTAL BICEPS IMPLANT SYSTEM REPEATEDLY FELL OFF WHILE LOADING OR IMPLANTING THE BUTTON. ANOTHER AR-2295 TWO-INCISION DISTAL BICEPS IMPLANT SYSTEM WAS OPENED, AND THE SAME ISSUE OCCURRED. THIS WAS DISCOVERED DURING A DISTAL BICEPS PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED ON 11/17/2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23697457 ↗MalfunctionMay 10, 2024Break; Break
ON 04/15/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT ONE OF THE INSERTERS FROM AN AR-2295 TWO INCISION DISTAL BICEPS IMPLANT SYSTEM SNAPPED OFF THE BUTTON WHEN ATTEMPTING TO INSERT THE BUTTON. THE BONE SOCKET WAS PREPPED WITH THE INSTRUMENTATION FROM THE KIT. THE BUTTON DID NOT DEPLOY, AND ALL THE FRAGMENTS WERE REMOVED. THE CASE WAS COMPLETED USING ANOTHER AR-2295 TWO INCISION DISTAL BICEPS IMPLANT SYSTEM. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 4/19/2024: THERE WAS NOTHING LOOSE INSIDE THE PATIENT WHEN THE INSERTER SNAPPED OFF AS IT AS CONTAINED WITHIN THE BUTTON. THE CASE WAS DELAYED ABOUT TWO MINUTES AND ADDITIONAL ANESTHESIA WAS UNNECESSARY.
Patient problems: Insufficient Information
MAUDE report 19287188 ↗
Other Fastener, fixation, nondegradable, soft tissue devices
- TRUESPAN ORTHOCORD 228151Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1,686 reports
- TRUESPAN ORTHOCORD 228152Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1,398 reports
- OMNISPAN ORTHOCORD 228142Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE932 reports
- FOOTPRINT 72202901Smith & Nephew, Inc. · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE721 reports
- RIGIDLOOP 232447Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE633 reports
- Arthrex® AR-3636Arthrex, Inc. · Fastener, fixation, nondegradable, soft tissue624 reports
- OMNISPAN ORTHOCORD 228141Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE609 reports
- TRUESPAN ORTHOCORD 228162Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE460 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page