Linvatec SRS CrossFT, HI-FI CFP-6503Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20845854013981), received between Mar 22, 2017 and Mar 22, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionMar 22, 2017Break; Material Deformation; Break; Material Deformation

  THE USER FACILITY REPORTED THAT DURING USE OF THE 6.5 MM CROSSFT SUTURE ANCHOR IN A ROTATOR CUFF REPAIR ARTHROSCOPY PROCEDURE ON (B)(6) 2017, "A PART OF THE INSERTER BROKE OFF". AS REPORTED, THE BREAKAGE OCCURRED DURING INSERTION OF THE ANCHOR. THE BROKEN PORTION OF THE DRIVER HEAD APPROXIMATELY 1 CM IN LENGTH WAS SAFELY RETRIEVED WITH A FORCEPS GRASPER. THE ANCHOR REMAINED IN PLACE AND FIT WELL. THE PROCEDURE WAS OTHERWISE COMPLETED WITH NO FURTHER COMPLICATIONS, NO PATIENT INJURY OR SURGICAL DELAY. DESPITE THE GOOD FAITH EFFORT, NO PATIENT DEMOGRAPHIC INFORMATION COULD BE OBTAINED FROM THE USER FACILITY. THIS REPORT IS FILED ON THE BASIC OF POTENTIAL FOR PATIENT INJURY WITH RECURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6425457 ↗

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.