THREVO, LINVATEC SRS, HI-FI CF6160HNRecalls & reported problems
Conmed Corporation · ThRevo -FT 5.0 mm Suture Anchor w/3 Hi-Fi No. 2 (5 metric) Sutures w/Needles · Class 2 · Implant
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 20845854018467), received between Nov 24, 2025 and Nov 24, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Expiration Date Error” (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.
Reports received per month
Most reported problems
Device problems
- Expiration Date Error1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 24, 2025Expiration Date Error; Expiration Date Error
THE SALES REPRESENTATIVE REPORTED THAT THE THAT THE CF6160HN 5.0MM SUTURE ANCHOR W/3 HI-FI #2(5 METRIC) SUTURES W/NEEDLES DEVICE WAS BEING USED DURING AN MCL REPAIR PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED ¿IMPLANTS WAS USED DURING OR AND HAD EXPIRY DATE OF 04/09.¿. FURTHER ASSESSMENT QUESTIONING FOUND THE EXPIRATION DATE WAS NOT CHECKED BEFORE IMPLANTATION OF THE DEVICE. OPERATION SUCCESSFULLY PERFORMED. ¿PHARMACIE NOTICED THAT THE IMPLANT THAT WAS USED WAS EXPIRED.¿. IT WAS ALSO CONFIRMED THAT DEVICE DID NOT MALFUNCTION IN ANY WAY DURING THE PROCEDURE. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23633970 ↗
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 · TerminatedNonabsorbable suture anchor system intended to reattach soft tissue to bone in orthopedic surgical procedures may be used in either arthroscopic or open surgical procedures.
Other Fastener, fixation, nondegradable, soft tissue devices
- TRUESPAN ORTHOCORD 228151Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1,686 reports
- TRUESPAN ORTHOCORD 228152Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1,398 reports
- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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