ZIPTIGHT FIXATION SYSTEM 904759Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00880304476103), received between Oct 31, 2019 and Sep 29, 2026 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Fracture” (20 reports).

1 FDA recall record name this device's identifier.

7 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.

Recalls naming this device

1. Aug 22, 2017Terminated

   Ziptight Ankle Syndesmosis Fixation was packaged without the tip protectors.

   Z-0818-2018 · Root cause: Packaging process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50940256 ↗
• MalfunctionJun 10, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING THE SURGERY, THE DEVICE COULD NOT BE PASSED THROUGH THE TIBIA OF THE PATIENT AND THE SUTURE OF THE DEVICE FRACTURED, LEADING TO AN APPROXIMATELY 15-MINUTE DELAY. THIS HAPPENED WITH TWO DEVICES. AS A RESULT, THE SURGEON FINISHED THE SURGERY WITH AN ALTERNATE DEVICE. NO COMPLICATIONS, INJURIES, OR SURGICAL INTERVENTIONS WERE REQUIRED, AND NO FOREIGN BODIES WERE RETAINED DUE TO THIS MALFUNCTION. THE CASE WAS COMPLETED WITHOUT ANY ADVERSE OUTCOMES TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22180058 ↗
• MalfunctionJun 10, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING THE SURGERY, THE DEVICE COULD NOT BE PASSED THROUGH THE TIBIA OF THE PATIENT AND THE SUTURE OF THE DEVICE FRACTURED, LEADING TO AN APPROXIMATELY 15-MINUTE DELAY. THIS HAPPENED WITH TWO DEVICES. AS A RESULT, THE SURGEON FINISHED THE SURGERY WITH AN ALTERNATE DEVICE. NO COMPLICATIONS, INJURIES, OR SURGICAL INTERVENTIONS WERE REQUIRED, AND NO FOREIGN BODIES WERE RETAINED DUE TO THIS MALFUNCTION. THE CASE WAS COMPLETED WITHOUT ANY ADVERSE OUTCOMES TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22180055 ↗
• MalfunctionMay 15, 2025Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22025442 ↗
• MalfunctionMar 10, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE SUTURES KEPT BREAKING WHEN TRYING TO TIGHTEN IT AFTER IT CAME IN CONTACT WITH THE PLATE. NO ADVERSE EVENT HAS BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21558876 ↗
• MalfunctionMar 10, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE SUTURES KEPT BREAKING WHEN TRYING TO TIGHTEN IT AFTER IT CAME IN CONTACT WITH THE PLATE. NO ADVERSE EVENT HAS BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21558873 ↗
• MalfunctionMar 10, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE SUTURES KEPT BREAKING WHEN TRYING TO TIGHTEN IT AFTER IT CAME IN CONTACT WITH THE PLATE. NO ADVERSE EVENT HAS BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21558867 ↗
• MalfunctionOct 23, 2024Fracture; Fracture

  IT WAS REPORTED THAT WHILE THE SURGEON WAS CLOSING THE SYSTEM, THE SUTURE FRACTURED AND BECAME LOOSE AND COMES OUT OF THE SYSTEM. THE SURGEON REMOVED THE DEVICE AND A SECOND ONE WAS USED TO COMPLETE THE SURGERY. THERE WAS NO FOREIGN BODY RETAINED OR HARM TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20517891 ↗
• MalfunctionOct 23, 2024Fracture; Fracture

  IT WAS REPORTED THAT WHILE THE SURGEON WAS COMPLETING THE PROCEDURE, ONE OF THE THREADS FRACTURED DURING CLOSURE. IT IS NOT KNOWN WHY THE THREAD FRACTURED, THE SURGICAL TECHNIQUE WAS COMPLETED, AND NO ADDITIONAL ELEMENT WAS USED TO CLOSE THE SYSTEM. THE ORIGINAL DEVICE WAS REMOVED FROM THE PATIENT AND A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF FOREIGN BODY RETAINED OR HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20517890 ↗
• MalfunctionMay 17, 2024Fracture; Fracture

  IT WAS REPORTED THE GUIDE WAS PASSED FOLLOWED BY THE DRILL. THEN THE PLATE CONDUCTING NEEDLE WAS INTRODUCED, THE PLATE IS ACCOMMODATED IN THE MEDIAL PART OF THE TIBIA, AND THE RESIDENT PROCEEDED TO PULL THE THREADS BY HAND IN A SINGLE BLOCK. IT WAS THEN ATTACHED TO THE FIBULA, WHICH FRACTURED, LEAVING THE SYSTEM WITHOUT THREADS TO CLOSE IT. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19341982 ↗
• MalfunctionFeb 28, 2023Fracture; Fracture

  IT WAS REPORTED DURING AN INITIAL PROCEDURE THE THREADS FRACTURED. THE FRACTURED PIECES WERE REMOVED AND A SCREW WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16455370 ↗
• MalfunctionNov 28, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE SUTURE FRACTURED DURING THE PROCEDURE. THE SURGEON USED ANOTHER PRODUCT TO COMPLETE THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15870997 ↗
• MalfunctionSep 16, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY, THE SUTURE BROKE DURING USE. NO PIECES WERE RETAINED BY THE PATIENT AND NO REPORTED CONSEQUENCES OCCURRED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15437719 ↗
• MalfunctionSep 16, 2022Fracture; Fracture

  IT WAS REPORTED THAT ONE OF THE SUTURES FRACTURED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED BY KNOTTING IT WITH THE OTHER SUTURES. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15437434 ↗
• MalfunctionAug 25, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING THE SURGERY, THE BLUE/WHITE ZIP STRANDS WAS BROKEN DURING USE ACCORDING TO THE NORMAL USAGE. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15292673 ↗
• MalfunctionAug 4, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE DURING THE SURGERY, HAIR LIKE DEBRIS WAS FOUND INSIDE THE STERILE PACKAGE. ANOTHER PRODUCT WAS USED TO COMPLETE THE SURGERY. NO ADVERSE EVENT HAS BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15162896 ↗
• MalfunctionJan 27, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING THE SURGERY, A FOREIGN SUBSTANCE THAT LOOKS LIKE DUST WAS FOUND INSIDE OF THE STERILE PACKAGING. ANOTHER PRODUCT WAS USED TO COMPLETE THE SURGERY. NO ADVERSE EVENT HAS BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13369464 ↗
• MalfunctionJan 27, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGERY, THE SUTURE OF THE ZIPLOOP BROKE WHEN THE SURGEON APPLIED TENSION. THE BROKEN COMPONENT WAS REMOVED FROM THE PATIENT'S BODY AND THE SURGEON USED A BACKUP DEVICE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES 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 13368960 ↗
• MalfunctionApr 7, 2021Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11627066 ↗
• MalfunctionDec 17, 2019Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9480114 ↗
• MalfunctionOct 31, 2019Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY WHILE REDUCING THE DEVICE, THE SUTURE FRACTURED. THERE WAS A DELAY OF 1.5 HOURS AS A RESULT OF THIS EVENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9261734 ↗
• MalfunctionOct 31, 2019Fracture; Fracture

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9261713 ↗
• MalfunctionOct 31, 2019Fracture; Fracture

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9261711 ↗

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-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