CrossFT CFK-475SRecalls & reported problems
Conmed Corporation · CrossFT Knotless 4.75 mm Suture Anchor · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10845854044605), received between Oct 10, 2017 and Oct 10, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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
Device problems
- Break1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 10, 2017Break; Break
THE USER FACILITY REPORTED DURING AND ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE, THE CROSSFT KNOTLESS 4.75 MM IMPLANT WAS UNABLE TO DEPLOY DUE TO IT BEING BROKEN AT THE DISTAL END. THE PROCEDURE WAS CONVERTED FROM ARTHROSCOPIC TO AN OPEN APPROACH DUE TO THIS AND CAUSED MORE THAN A 30-MINUTE SURGICAL DELAY. ADDITIONAL INFORMATION WAS OBTAINED VIA EMAIL AND THE PATIENT WAS SAID TO HAVE POOR BONE. THE DOCTOR WAS OPERATING WITH THIS DEVICE FOR THE FIRST TIME IN A CLINICAL SETTING AND WAS EXPERIENCING POOR VISUALIZATION. THE PATIENT WAS OPENED DUE TO THE SHOULDER BEING DISTENDED FOR TOO LONG AND THE DOCTOR WAS UNABLE TO ESTABLISH ADEQUATE VISUALIZATION IN ORDER TO INSERT THE ANCHOR. THIS REPORT IS RAISED ON THE BASIS OF A SURGICAL APPROACH CHANGING FROM ARTHROSCOPIC TO OPEN. THIS INCIDENT WILL BE REPORTED AS A PATIENT INJURY.
Patient problems: No Code Available
MAUDE report 6938432 ↗
Other Fastener, fixation, nondegradable, soft tissue devices
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- OMNISPAN ORTHOCORD 228142Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE932 reports
- FOOTPRINT 72202901Smith & Nephew, Inc. · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE721 reports
- RIGIDLOOP 232447Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE633 reports
- Arthrex® AR-3636Arthrex, Inc. · Fastener, fixation, nondegradable, soft tissue624 reports
- OMNISPAN ORTHOCORD 228141Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE609 reports
- TRUESPAN ORTHOCORD 228162Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE460 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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