CrossFix® II Meniscal Repair Device CM8002Recalls & reported problems
Cayenne Medical, Inc. · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887868270055), received between Apr 29, 2022 and Jan 19, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Firing Problem” (3 reports).
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
- Firing Problem3
- Misfire2
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 19, 2024Misfire; Firing Problem; Misfire; Firing Problem
IT WAS REPORTED THAT DURING SURGERY, THE PRODUCT MISS FIRED WHILE TRYING TO REPAIR THE MENISCUS. A SIMILAR DEVICE WAS USED TO COMPLETE THE PROCEDURE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18547770 ↗MalfunctionJan 19, 2024Misfire; Firing Problem; Misfire; Firing Problem
IT WAS REPORTED THAT DURING SURGERY, THE PRODUCT MISS FIRED WHILE TRYING TO REPAIR THE MENISCUS. A SIMILAR DEVICE WAS USED TO COMPLETE THE PROCEDURE.ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18547756 ↗MalfunctionApr 29, 2022Firing Problem; Firing Problem
IT WAS REPORTED DURING A MENISCAL SUTURE OPERATION, THE IMPLANTS DID NOT WORK AS THE SUTURE CAME OUT WITHOUT A KNOT. NO PATIENT IMPACT, NO DELAY. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14250682 ↗
Other Suture, nonabsorbable, synthetic, polyethylene devices
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- FAST-FIX 72205676Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE439 reports
- Arthrex® AR-4501Arthrex, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE403 reports
- FAST-FIX 72205324Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE383 reports
- LUPINE ORTHOCORD 210712Medos International Sàrl · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE357 reports
- FAST-FIX 72201494Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE249 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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