ZIPTIGHT 904835Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00880304478824), received between May 20, 2024 and May 20, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (1 report).

8 other recalls cover devices cleared under the same FDA submission (K083070, K130033); they may or may not involve this specific model.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2024Fracture; Fracture

  IT WAS REPORTED IN THE MIDDLE OF THE PROCEDURE WHEN THE IMPLANT WAS OPENED FROM THE PACKAGING, AN INCONSISTENCY WAS NOTED IN THE LOOPS, THE SURGEON GENERATED TENSION TO SEE IF IT COULD BE RESISTANT DURING THE PROCEDURE, BUT IT FRACTURED. THEREFORE, ANOTHER IMPLANT WAS USED TO COMPLETE THE PROCEDURE. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19350349 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083070, K130033. One submission often covers many models, so check the product and lot details in each record.

• Z-0212-2026 · Sep 23, 2025 · Open, Classified
  BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834; Fixation System for AC Joint Repair
• Z-0818-2018 · Aug 22, 2017 · Terminated
  Ziptight Ankle Syndesmosis Fixation Device, Titanium Implant Titanium Implant for surgical repairs of soft tissue.
• Z-1828-2016 · Apr 1, 2016 · Terminated
  Various trauma and sports medicine instruments and implants. Fastener, fixation, nondegradable, soft tissue.
• Z-1363-2015 · Feb 26, 2015 · Terminated
  ToggleLoc; fastener, fixation, non degradable, soft tissue; Artificial Ligament Fixation Device #7 PE Ziploop Extended Toggleloc Product Usage: The Toggleloc System is a non-resor
• Z-1952-2010 · Mar 31, 2010 · Terminated
  Artificial ligament fixation device # 7PE ZIPLOOP Extended Toggle, Sterile, REF 904755, Biomet Sports Medicine Warsaw, IN. Intended for soft tissue to bone fixation.
• Z-1953-2010 · Mar 31, 2010 · Terminated
  Toggleloc Artificial ligament fixation device ZIPLOOP Technology Implant Kit, Sterile, REF 909848, Biomet Sports Medicine Warsaw, IN. Intended for soft tissue to bone fixation.
• Z-0559-2010 · Nov 10, 2009 · Terminated
  Toggleloc System, Biomet Ziptight Ankle Syndesmosis Fixation System - Titanium with Ziploop Technology, polyethylene/polypropylene/ polyester/TI-6AL-4V alloy/S.S., sterile Biomet S
• Z-0560-2010 · Nov 10, 2009 · Terminated
  Toggleloc System, Biomet Ziptight Ankle Syndesmosis Fixation System - SS with Ziploop Technology, polyethylene/polypropylene/ polyester/ stainless steel, sterile Biomet Sports Medi