Arthrex® AR-11041XLFRecalls & reported problems
Arthrex, Inc. · Pnch, WB XL, 2.75 15U Cv w/FlushPort · Class 1
Data updated Oct 16, 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 00888867272842), received between Dec 9, 2019 and Dec 9, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Deformation Due to Compressive Stress1
Patient problems
- Abrasion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 9, 2019Deformation Due to Compressive Stress
IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY THE ARTHREX DEVICE AR-11041XLF WAS USED. THE DEVICE PRODUCES METAL ABRASION. THE METAL ABRASION IS SO THIN AND SMALL THAT IT WAS NOT POSSIBLE TO RETRIEVE EVERYTHING FROM THE JOINT OF THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH THE COMPLAINT DEVICE. NO FURTHER INFORMATION RECEIVED BY THE CUSTOMER.
Patient problems: Abrasion
MAUDE report 9440203 ↗
Other INSTRUMENT, MANUAL, SURGICAL, GENERAL USE devices
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- Arthrex® AR-12990NArthrex, Inc. · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE197 reports
- Arthrex® AR-13991NArthrex, Inc. · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE128 reports
- Arthrex® AR-8981-08SArthrex, Inc. · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE1 recall3 reports
- Arthrex® AR-8981-06SArthrex, Inc. · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE1 recall1 report
- Centurion EB16Centurion Medical Products Corporation · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE1 recall0 reports
- Medline Industries, Inc. DYNJ901391DMedline Industries, Inc. · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE1 recall0 reports
- HarmonyAIR LAS0042Steris Corporation · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE1 recall0 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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