FiberStitch™ Implant 1.5, Straight (RC) with two Polyester Implants and 2-0 Fibe AR-19032SRecalls & reported problems
T.A.G Medical Products Agricultural Cooperative Association · FiberStitch™ Implant 1.5, Straight (RC) with two Polyester Implants and 2-0 FiberWire Suture · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10818674027417), received between Oct 29, 2024 and Oct 29, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (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
- Patient Device Interaction Problem1
Patient problems
- Hypersensitivity/Allergic reaction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 29, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
ON 10/15/2024, IT WAS REPORTED BY A PATIENT VIA PHONE THAT SHE WAS EXPERIENCING PAIN AND INFLAMMATION POST-OPERATIVELY AND INQUIRED ABOUT THE MATERIAL COMPOSITION OF SEVERAL KNOWN AND UNKNOWN ARTHREX PRODUCTS. DURING AN INITIAL ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023, QTY. 2 OF AN AR-2324BCM SUTURE ANCHOR, BIO-COMPOSITE SWIVELOCK SP, AN AR-3633SP FIBERTAK SP SUTURE ANCHOR, AND AN AR-3670 FIBERTAK BICEPS IMPLANT SYSTEM WERE IMPLANTED. AFTER 6 WEEKS POST-OP, THE PATIENT EXPERIENCED INCREASING PAIN AND INFLAMMATION, BUT THE INITIAL SURGEON DID NOT WANT TO PERFORM REVISION SURGERY AND STATED THAT NOTHING WAS WRONG. THE PATIENT THEN WENT TO ANOTHER SURGEON WHO PERFORMED REVISION SURGERY ON THE RIGHT SHOULDER ON (B)(6) 2024. IT WAS FOUND THAT THE SUTURES TO ONE OF THE ANCHORS WERE LOOSE; NOTHING HAD BROKEN INSIDE THE PATIENT. THE SURGEON CUT THE LOOSE SUTURES AND REMOVED THEM, BUT THE ANCHOR AND ALL OTHER DEVICES FROM THE INITIAL SURGERY REMAINED INSIDE THE PATIENT. DURING THE ADDITIONAL PROCEDURE, ADDITIONAL UNKNOWN ARTHREX SUTURE ANCHORS, SWIVELOCK ANCHORS, AND A GRAFT WERE IMPLANTED USING THE ARTHREX CUFFMEND SYSTEM. AFTER THE ADDITIONAL SURGERY, THE PATIENT EXPERIENCED PAIN AND
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 20560500 ↗
Other Fastener, Fixation, Nondegradable, Soft Tissue devices
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- 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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