GENESYS CROSSFT, HI-FI, LINVATEC SRS CFBC-5502NRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20845854034597), received between Mar 7, 2017 and Mar 7, 2017 — classified as 1 injury.

2 other recalls cover devices cleared under the same FDA submission (K101100); 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.

• InjuryMar 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT THE PATIENT EXPERIENCED A POST-OP COMPLICATION AFTER THE USE OF THE GENESYS CROSSFT 5.5MM SUTURE ANCHOR THAT REQUIRED A SURGICAL INTERVENTION APPROXIMATELY 7 MONTHS AFTER THE ORIGINAL SURGERY. FOLLOW-UP WITH THE USER FACILITY REVEALED THAT THE PATIENT HAD FALLEN ON HER ARM AND SUSTAINED A BONY AVULSION OF HER SUPRASPINATUS TENDON. AN INITIAL ARTHROSCOPY OF THE SHOULDER ON (B)(6) 2016 SHOWED A SMALL PARTIAL ARTICULAR SUPRASPINATUS TENDON AVULSION (PASTA) LESION UNDER A POST TRAUMATIC ADHESIVE CAPSULITIS. IN A FOLLOW-UP CT SCAN OF THE SHOULDER BECAUSE OF ON-GOING SHOULDER PAIN, A BONE FRAGMENT WAS DETECTED IN THE HEALED SUPRASPINATUS TENDON IN THE SUBSCROMIAL SPACE. THE PATIENT THEN UNDERWENT A SECOND SHOULDER ARTHROSCOPY TO REMOVE A "BONE FRAGMENT FROM HER SUPRASPINATUS TENDON AND REPAIR THE DEFECT IN THE TENDON" BY USING A GENESYS CROSSFT 5.5MM SUTURE ANCHOR ON (B)(6) 2016. AS REPORTED, THE PROCEDURE WAS COMPLETED WITH NO PROBLEMS REPORTED. HOWEVER, APPROXIMATELY 7-MONTHS POST-OP DURING A ROUTINE POST-OP FOLLOW-UP EXAMINATION ON (B)(6) 2017, MRI PHOTOS WERE TAKEN AND SHOWED "MASSIVE DAMAGE" OF THE HUMERAL HEAD. THE SURGEON ELECTED TO PERFORM A 3RD AR

  Patient problems: Local Reaction

  MAUDE report 6383489 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K101100. One submission often covers many models, so check the product and lot details in each record.

• Z-3018-2026 · Jul 14, 2026 · Open, Classified
  CONMED Linvatec GENESYS CrossFT Suture Anchor with Disposable Driver REF# CFBC-5502B 5.5mm GENESYs CrossFT Suture Anchor with two, #2 (5 metric) Hi-Fi Sutures Sterile
• Z-1619-2013 · Mar 6, 2013 · Terminated
  GENESYS Cross FT Suture Anchor with Two #2 (5 metric) Hi-FI Registered Trade Mark Sutures Rx Only STERILE EO CONMED LINVATEC REF CFBC-4502. Reattachment of soft tissue to bone in