ZIPTIGHT FIXATION SYSTEM 909857Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00880304475854), received between Mar 27, 2025 and Mar 27, 2025 — 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.

• MalfunctionMar 27, 2025Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21708302 ↗

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-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
• 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