ToggleLoc With Ziploop 904754Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00880304464858), received between Dec 30, 2024 and Jun 2, 2026 — classified as 1 injury, 2 malfunctions.

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

9 other recalls cover devices cleared under the same FDA submission (K033838, K083070, K130033, K973775); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2026Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DURING A PROCEDURE, THE STERILE PACKAGING WAS NOTED TO BE TORN. THIS WAS STATED TO HAVE BEEN NOTED OUTSIDE OF THE STERILE ZONE AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES WERE REPORTED AS A RESULT OF THE EVENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25361359 ↗
• InjuryJan 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 4 MONTHS POST IMPLANTATION DUE TO ASEPTIC FUNGAL INFECTION, SEVERE PAIN AND AMBULATION DIFFICULTY. THE PATIENT WAS EXPERIENCING CHILLS, NIGHT SWEATS, FEVER, AND KNEE PAIN IMMEDIATELY AFTER THE INITIAL PROCEDURE AND THIS CONTINUED UNTIL THE REVISION OCCURRED WHERE AN ACL GRAFT AND THE HARDWARE WAS REMOVED. THE PATIENT HAS CONTINUED TO HAVE PAIN AND MOBILITY ISSUES AND AN ADDITIONAL PROCEDURE TO REMOVE FUNGAL GROWTH OCCURRED APPROXIMATELY 5 MONTHS POST OP.ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Ambulation or Postural Difficulties; Chills; Fever; Fungal Infection; Pain

  MAUDE report 21210719 ↗
• MalfunctionDec 30, 2024Fracture; Fracture

  IT WAS REPORTED THAT WHILE THE SURGEON WAS ATTEMPTING TO PULL THE SUTURES TO PLACE THE IMPLANT IN PLACE, THE SUTURES FRACTURED AND THE SURGEON WAS UNABLE TO IMPLANT THE GRAFT. THE SURGEON REMOVED THE IMPLANT AND USED A SECOND IMPLANT TO IMPLANT THE GRAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21035013 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033838, K083070, K130033, K973775. 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
• Z-0582-2012 · Apr 24, 2008 · Terminated
  Artificial Ligament Fixation Device 15MM TI NS ToggleLoc (TM) W/Continuous Maxbraid Polyethylene Suture Loop TO Gal 4V Alloy/Polyethylene; Artificial Ligament Fixation Device 25MM