Arthrex® AR-7258Recalls & reported problems
Arthrex, Inc. · FiberLink 0, blue · Class 2 · Implant
Data updated Oct 13, 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 00888867237896), received between Jun 3, 2024 and Jun 3, 2024 — 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 3, 2024Break; Break
ON 3/24/2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-19021TT TISSUE TAK TENDON ANCHOR DURING A ROTATOR CUFF SHOULDER PROCEDURE MALFUNCTIONED AND TORE THE GRAFT. THE GRAFT HAD TO BE REMOVED AND REPLACED. ALL OF THE IMPLANTS WERE IMPLANTED PROPERLY AND REMAIN IN THE PATIENT . ANOTHER GRAFT WAS USED AND THE TENDON ANCHOR WAS REPLACED. ADDITIONAL IMPLANTS WERE USED TO COMPLETE THE CASE SUCCESSFULLY. THE PATIENT TO FINE TO DATE WITH NO AFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19447359 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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