Arthrex® AR-5068-25TLRecalls & reported problems
Arthrex, Inc. · SUTRLASSO SD SFT,25°TIGHT LFT CRV,R · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867035584), received between Sep 6, 2024 and Jan 23, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 23, 2026Break; Material Twisted/Bent
ON (B)(6) 2026, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT SUTRLASSO SD SFT,45°RT CRV, R AR-5068-45R LOT 0072332 WAS BENT AND SUBSEQUENTLY BROKE DURING THE PROCEDURE PM (B)(6) 2026. THE SURGERY WAS COMPLETED WITHOUT COMPLICATIONS USING A NEW (AR-5068-XX) WITH NO FRAGMENTS RETAINED IN THE PATIENT¿S BODY AND NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24160493 ↗MalfunctionSep 6, 2024Break; Break
ON 08/16/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-5068-25TL SUTURELASSO SD SHAFT BROKE DURING SURGERY (PHOTO IS ATTACHED) WITH NO ADVERSE EFFECTS ON THE PATIENT. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20161000 ↗
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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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