KATOR, LLC 1030592Recalls & reported problems
Kator, LLC · KATOR Suture Anchor, Arthroscopic, 5.0mm x 25mm, #2 Suture · Class 2
Data updated Oct 18, 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 B18610305920), received between Feb 8, 2017 and Feb 8, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Premature Activation” (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 18, 2026.
Most reported problems
Device problems
- Premature Activation1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 8, 2017Premature Activation; Premature Activation
DURING ARTHROSCOPIC ROTATOR-CUFF-REPAIR SURGERY, THE BREAKAWAY HEAD ON THE SUTURE ANCHOR BROKE PREMATURELY AND PRIOR TO SUTURE LOCK OUT. THE ANCHOR AND LOCKING PIN WERE REMOVED AND THE SUTURES WERE UNTHREADED FROM THE ANCHOR. A SECOND ANCHOR WAS PLACED AND PERFORMED AS INTENDED. THE FINAL SURGICAL RESULT WAS AS DESIRED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6311835 ↗
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- FOOTPRINT 72202901Smith & Nephew, Inc. · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE721 reports
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- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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