Linvatec SRS CrossFT, HI-FI CFP-4502Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20845854014230), received between Dec 22, 2022 and Dec 22, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (1 report).

1 other recall cover devices cleared under the same FDA submission (K091549); they may or may not involve this specific model.

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.

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.

• MalfunctionDec 22, 2022Material Fragmentation; Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT 4.5MM CROSSFT SUTURE ANCHOR WAS BEING USED DURING AN FIFTH FINGER FLEXOR RECONSTRUCTION PROCEDURE ON (B)(6) 2022, WHEN IT WAS REPORTED, ¿THE IMPLANT FRACTURES WHEN ENTERING THE HOLE¿. THE PROCEDURE WAS COMPLETED WITH THE USE OF AN ALTERNATE SUPER REVO FT DEVICE AND A 4 MINUTE DELAY WAS REPORTED IN THE PROCEDURE. FURTHER ASSESSMENT ANSWERS WERE REQUESTED OF THE REPORTER AND A GOOD FAITH EFFORT WAS COMPLETED; HOWEVER, THE REPORTER HAS NOT RESPONDED TO OUR ATTEMPTS FOR INFORMATION. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO POSSIBLE RETAINED FOREIGN OBJECT IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16035049 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K091549. One submission often covers many models, so check the product and lot details in each record.

• Z-0253-2018 · Apr 17, 2017 · Terminated
  Nonabsorbable suture anchor system intended to reattach soft tissue to bone in orthopedic surgical procedures may be used in either arthroscopic or open surgical procedures.