RipCord STA001KRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00842188123849), received between Dec 15, 2022 and Dec 15, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Dec 22, 2022Open, Classified

   Overly aggressive tension on the pull suture, while passing the medial button through a bone/soft tissue tunnel across the fibula and tibia, can exceed its strength causing it to break.

   Z-1101-2023 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 15, 2022Material Separation; Material Separation

  JIM FASSETT WAS NOTIFIED ON 02DEC2022 THAT THE PULL SUTURE IN STA001K SEPARATED FROM THE MEDIAL BUTTON DURING SURGERY. IT WAS REPORTED THAT THE MEDIAL BUTTON WAS THROUGH THE FIBULAR AND TIBIAL BONE TUNNELS AND SUCCESSFULLY DEPLOYED ON THE MEDIAL CORTEX. THE SALES REP REPORTED THAT THIS DID NOT CAUSE A DELAY IN SURGERY NOR DID IT CAUSE THE PATIENT ADDITIONAL HARM. THERE ARE NO PICTURES AVAILABLE AND THE DEVICE IS NOT AVAILABLE FOR RETURN.

  Patient problems: Damage to Ligament(s)

  MAUDE report 15993141 ↗
• MalfunctionDec 15, 2022Material Separation; Material Separation

  JIM FASSETT WAS NOTIFIED ON 02DEC2022 THAT THE PULL SUTURE IN STA001K SEPARATED FROM THE MEDIAL BUTTON DURING SURGERY. IT WAS REPORTED THAT THE MEDIAL BUTTON WAS THROUGH THE FIBULA BONE TUNNEL, BUT NOT YET IN THE TIBIAL BONE TUNNEL ALLOWING THE SURGEON TO RETRIEVE THE DEVICE ENOUGH TO APPLY AN OFF-THE-SHELF PASSING SUTURE / NEEDLE THAT WAS RETHREADED THROUGH THE PULL SUTURE HOLE IN THE LEADING EDGE OF THE BUTTON. THE SALES REP REPORTED THAT THIS DID NOT CAUSE A DELAY IN SURGERY NOR DID IT CAUSE THE PATIENT ADDITIONAL HARM. THERE ARE NO PICTURES AVAILABLE AND THE DEVICE IS NOT AVAILABLE FOR RETURN.

  Patient problems: Damage to Ligament(s)

  MAUDE report 15993140 ↗