Arthrex® AR-1588AU-CP2Recalls & reported problems
Arthrex, Inc. · IMPL SYS, AUTOGRAFT GRAFTLINK CP 2 · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867395367), received between Aug 22, 2023 and Jul 1, 2025 — classified as 5 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
- Component Missing1
- Material Split, Cut or Torn1
Patient problems
- Insufficient Information4
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 1, 2025Break; Break
ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-1588AU-CP2 IMPLANT SYSTEMS TITANIUM BUTTON ON THE RT2 IMPLANT SNAPPED. THIS OCCURRED DURING AN ACL RECONSTRUCTION ON (B)(6) 2025. THIS OCCURRED DURING AN ACL RECONSTRUCTION ON (B)(6) 2025. THERE WAS A DELAY OF ABOUT 2 HOURS. ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE PROCEDURE WAS COMPLETED USING ANOTHER AR-1588AU-CP2 IMPLANT SYSTEM.
Patient problems: Insufficient Information
MAUDE report 22374607 ↗MalfunctionFeb 10, 2025Break; Break
ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT THE SURGEON USED STANDARD TECHNIQUE TO USE AN AR-1588AU-CP2 AUTOGRAFT GRAFTLINK IMPLANT SYSTEM THE ENTIRE WAY THROUGH THE USE OF THE FLIPCUTTER 3. UPON REAMING ABOUT 1CM OR SO, THE TIP SHEERED OFF. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT. THE CASE WAS COMPLETED. THIS WAS DISCOVERED DURING AN ACL/PCL RECONSTRUCTION PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 01/21/2025: THE CASE WAS COMPLETED USING A FLIPCUTTER. THERE WAS A FIVE-MINUTE DELAY IN THE CASE, WITH FIVE MINUTES OF ADDED ANESTHESIA ADMINISTERED TO THE PATIENT. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 21344537 ↗MalfunctionJan 8, 2025Break; Break
ON (B)(6) 2024, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-1588AU-CP2 AUTOGRAFT GRAFTLINK IMPLANT SYSTEM HAD THE TIGHTROPE SNAPPED WHEN TENSIONING. THE BROKEN TIGHTROPE WAS REMOVED FROM THE PATIENT, AND ANOTHER OF THE SAME PRODUCT WAS USED TO COMPLETE THE CASE. THERE WAS A FIVE-MINUTE DELAY IN THE CASE. THIS WAS DISCOVERED DURING AN ACL PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21102447 ↗MalfunctionOct 3, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
ON 9/25/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE TIGHTROPE II FROM AN AR-1588AU-CP2 AUTOGRAFT GRAFTLINK IMPLANT SYSTEM ON THE FEMORAL SIDE HAD THE SUTURES CUT AT THE BUTTON WHILE TENSIONING. THIS CAUSED THE GRAFT TO BE UNDER TENSION. THE GRAFT WAS CUT OUT, AND A NEW AR-1588AU-CP2 AUTOGRAFT GRAFTLINK IMPLANT SYSTEM WAS USED TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING AN ACLR PROCEDURE ON 9/25/2024. ADDITIONAL INFORMATION RECEIVED ON 9/27/2024: THIS WAS DISCOVERED ON THE BACK TABLE WHILE PREPPING THE GRAFT. THE CASE WAS DELAYED ABOUT TEN MINUTES, BUT ADDITIONAL ANESTHESIA WAS NOT NEEDED.
Patient problems: Insufficient Information
MAUDE report 20358682 ↗MalfunctionAug 22, 2023Component Missing; Component Missing
ON 7/24/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1588AU-CP2 AUTOGRAFT GRAFLINK IMPLANT SYSTEM WAS MISSING THE FIBERLINK. THIS WAS DISCOVERED UPON OPENING THE PACKAGE DURING A PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON 7/28/2023: THIS WAS DISCOVERD DURING AN ACLR PROCEDURE AND COMPLETED USING AN AR-1588BTB-2J TIGHTROPE II BTB AND AN AR-1588TN-21 TIGHTROPE II ABS.
Patient problems: Insufficient Information
MAUDE report 17594543 ↗
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.
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