Arthrex® AR-1925SFRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867023192), received between Sep 10, 2018 and Sep 10, 2018 — classified as 1 injury.

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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA E-MAIL THAT DURING A SHOULDER SURGERY IN (B)(6) 2017 A CORKSCREW ANCHOR WAS USED. CORKSCREW-ANCHOR 6.5MM X 15.5MM, PART NO. AR-1925SF. THE PATIENT SUFFERS FROM MULTIPLE ALLERGIES. NOW THAT THE SHOULDER IS REDDENED AND SWOLLEN AGAIN, THE GENERAL PRACTITIONER NEEDS A "ALLERGY PLATELET" FROM ARTHREX AND THE DETAILED MATERIAL COMPOSITION OF THE ANCHOR TO EXCLUDE AN ALLERGIC REACTION. UPDATE 10SEP2018: ACCORDING TO SURGEON WHO PERFORMED SURGERY: NO TITANIUM ALLERGY IS KNOWN, ALLERGY TEST ON THE MATERIAL "PEEK" WAS PERFORMED. SURGEON CANNOT PROVIDE ANY FURTHER INFORMATION FOR DATA PROTECTION REASONS. FURTHER INFORMATION WAS ASKED.

  Patient problems: Erythema; Hypersensitivity/Allergic reaction; Joint Swelling

  MAUDE report 7861094 ↗