MENIX DUO Meniscal suture system, 2 anchorsRecalls & reported problems
S.B.M · MENIX® DUO system consists of a single-use launcher which deploys a nonabsorbable implant composed of two anchors connected by a suture. · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03760304680526), received between Mar 10, 2026 and Apr 29, 2026 — classified as 2 malfunctions.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Material Twisted/Bent1
Patient problems
- Insufficient Information2
- Foreign Body In Patient1
- Rupture1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 29, 2026Material Twisted/Bent
(B)(4). INCIDENT OCCURED IN FRANCE. COMPLAINT DESCRIPTION: OBSERVATION IN 1 PHOTO: DEFORMED NEEDLE TIPS - MESSAGE: "SHARP TIP NOT REMOVED".
Patient problems: Foreign Body In Patient; Insufficient Information
MAUDE report 25030342 ↗MalfunctionMar 10, 2026Break
(B)(4) INCIDENT OCCURED IN ARGENTINA. COMPLAINT DESCRIPTION: EVENT DESCRIPTION: "THE PEEK IMPLANTS DID NOT DEPLOY PROPERLY. IN THE FIRST CASE, THE REPAIR APPEARED TO BE WELL FIXED; HOWEVER, WHEN TYING THE KNOT, THE SUTURE BROKE. A SECOND DEVICE WAS USED, BUT THE IMPLANTS FAILED TO PROPERLY DEPLOY BEHIND THE CAPSULE. A THIRD DEVICE WAS THEN USED, AND THE SAME ISSUE OCCURRED. A TOTAL OF THREE DEVICES WERE INVOLVED: TWO UNITS FROM BATCH 254186 AND ONE UNIT FROM BATCH 254178. ALL THREE ISSUES OCCURRED DURING THE SAME SURGERY. THE SURGERY DURATION WAS APPROXIMATELY 40 MINUTES. THE PHYSICIAN CONSIDERED IT A DIFFICULT CASE TO REPAIR. THE JOINT WAS DEFINED AS CHALLENGING DUE TO THE LIMITED WORKING SPACE AND THE COMPLEXITY OF THE LESION. AS THE MENISCAL REPAIR COULD NOT BE SUCCESSFULLY COMPLETED USING SUTURES, THE PROCEDURE WAS FINALIZED WITH A PARTIAL MENISCECTOMY".
Patient problems: Insufficient Information; Rupture
MAUDE report 24556006 ↗
Other Suture, Nonabsorbable, Synthetic, Polyethylene devices
- FAST-FIX 72202468Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 death6,626 reports
- FAST-FIX 72201491Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE863 reports
- FAST-FIX 72202469Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE561 reports
- 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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