GENESYS CrossFT, Hi-Fi CFBC-5502BRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20845854042479), received between Apr 21, 2022 and Apr 21, 2022 — classified as 1 malfunction.

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

1 FDA recall record name this device's identifier, 1 still open.

1 other recall 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.

Recalls naming this device

1. Jul 14, 2026Class IIOpen, Classified

   Suture anchor may contain incorrect patient implant card which may result in incorrect device identification and traceability.

   Z-3018-2026 · Root cause: Labeling design · Recall details · FDA record ↗

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.

• MalfunctionApr 21, 2022Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, CFBC-5502B, 5.5MM GENESYS CROSSFT SUTURE ANCHOR, WAS BEING USED ON (B)(6) 2022 DURING A ROTATOR CUFF REPAIR PROCEDURE WHEN IT WAS REPORTED THAT THE ¿ANCHOR BROKE INTO MULTIPLE PIECES WHEN THE SURGEON TRIED IMPLANTING IT INTO PATIENT'S SHOULDER.¿ THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE WITH A 2 MINUTE DELAY. FURTHER ASSESSMENT FOUND THAT DR. (B)(6) WAS THE SURGEON, THE DEVICE WAS RETRIEVED, THE INTERVENTION WAS OPENING A NEW ANCHOR, THE PATIENT WASN'T INJURED, THE PATIENT WASN'T EFFECTED, THERE WAS NO EXTENDED STAY NEEDED. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14171976 ↗

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-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