Arthrex® AR-7268RRecalls & reported problems
Arthrex, Inc. · Radiopaque FiberTape Cerclage w/o Needle · Class 2 · Implant
Data updated Oct 16, 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 00888867392021), received between Nov 5, 2025 and Nov 5, 2025 — 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
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.
MalfunctionNov 5, 2025Break; Break
ADDITIONAL INFORMATION THE CASE WAS COMPLETED USING A REPLACEMENT AR-7268R RADIOPAQUE FIBERTAPE CERCLAGE. THERE WAS NO CASE DELAY AND NO ADDITIONAL ANESTHESIA ADMINISTERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23475406 ↗MalfunctionNov 5, 2025Break; Break
THE CASE WAS COMPLETED USING A REPLACEMENT AR-7268R RADIOPAQUE FIBERTAPE CERCLAGE. THERE WAS NO CASE DELAY AND NO ADDITIONAL ANESTHESIA ADMINISTERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23475302 ↗
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- Arthrex® AR-4501Arthrex, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE403 reports
- FAST-FIX 72205324Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE383 reports
- LUPINE ORTHOCORD 210712Medos International Sàrl · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE357 reports
- FAST-FIX 72201494Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE249 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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