FiberStitch™ Implant, 24° Curve with two Polyester Implants and 2-0 FiberWire® S AR-4570-24Recalls & reported problems
T.A.G Medical Products Agricultural Cooperative Association · 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 10818674025703), received between Oct 17, 2022 and Jul 5, 2024 — 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
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 5, 2024
PT CAME IN FOR RIGHT KNEE ARTHROSCOPY ACL REPAIR. IN THE MIDDLE OF SURGERY, FIBERSTITCH TIP BROKE OFF INSIDE PT. AND MD RETRIEVED THE BROKEN PIECE AND CASE CONTINUED. PT DISCHARGED TO PACU IN STABLE CONDITION. ENTIRE FIBERSTITCH UNIT RETRIEVED AND GIVEN TO NURSE MANAGER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19679744 ↗MalfunctionOct 17, 2022Break
PATIENT PRESENTED TO OPERATING ROOM FOR RIGHT KNEE ARTHROSCOPY REPAIR OF MEDIAL MENISCUS. DURING THE PROCEDURE A 25MM PIECE OF ARTHREX FIBERSTITCH BROKE OFF INTO PATIENT. THE BROKEN PIECE WAS RETRIEVED INTACT. FDA SAFETY REPORT ID# (B)(4).
Patient problems: Foreign Body In Patient
MAUDE report 15626112 ↗
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- 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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