ZIPTIGHT FIXATION SYSTEM 909853Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00880304476097), received between Oct 31, 2019 and Sep 1, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Fracture” (15 reports).

3 other recalls cover devices cleared under the same FDA submission (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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50551024 ↗
• MalfunctionMay 13, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY, THE DEVICE COULD NOT BE CONTRACTED AND THE SUTURE FRACTURED. THERE WAS NO HARM, INJURY, SURGICAL/MEDICAL INTERVENTION TO PATIENT AND NO REPORT OF A DELAY. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22008774 ↗
• MalfunctionMar 25, 2024Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18975829 ↗
• MalfunctionJan 16, 2024Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18517823 ↗
• MalfunctionJan 16, 2024Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18517797 ↗
• MalfunctionJan 16, 2024Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18517776 ↗
• MalfunctionJul 6, 2023Fracture; Fracture

  IT WAS REPORTED, THAT DURING THE SURGERY. THE SUTURE BROKE, WHEN THE SURGEON TRIED TO TIGHTEN THE SUTURE TO SET THE ROUND TOP HAT BUTTON, TO SEAT TO THE INTENTIONAL POSITION. NO PATIENT CONSEQUENCES WERE REPORTED FOR THIS EVENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17270752 ↗
• MalfunctionApr 18, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING THE SURGERY, THE SUTURE FRACTURED. THEREFORE, THE SURGEON REMOVED THIS PRODUCT FROM THE PATIENT'S BODY, AND USED A BACK UP OF THE SAME PRODUCT FOR THE SURGERY. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16764475 ↗
• MalfunctionMar 9, 2023Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16512823 ↗
• MalfunctionJan 3, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGERY, THE SUTURE SYSTEM BROKE IN TWO. THE EVENT OCCURRED PRIOR TO THE DEVICE BEING USED ON THE PATIENT. 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 16088167 ↗
• MalfunctionSep 23, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE SUTURE BROKE AS THE SURGEON WAS TIGHTENING THE IMPLANT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15469742 ↗
• 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 15292677 ↗
• MalfunctionDec 30, 2019Fracture; Fracture

  NO ADDITIONAL EVENT INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9529771 ↗
• MalfunctionNov 15, 2019Fracture; Fracture

  IT WAS REPORTED THE SUTURE BROKE DURING IMPLANTATION. THE SURGERY WAS COMPLETED WITH ANOTHER DEVICE WITH NO DELAY TO SURGERY. NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9328198 ↗
• 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 9261702 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under 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-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