ZIPTIGHT 904834Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00880304478404), received between Jan 9, 2020 and Jan 5, 2026 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Sep 23, 2025Open, Classified

   There is a potential for a missing slotted button assembly in one lot of ZipTight, Acute AC Joint Implant, Single Ziploop

   Z-0212-2026 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING SURGERY, A FOREIGN SUBSTANCE RESEMBLING A HAIR WAS OBSERVED ATTACHED TO THE STERILE PACKAGE INSIDE THE OUTER STERILE PACKAGING, AND THE PRODUCT WAS NOT USED. THE FINDING OCCURRED WHEN THE NURSE OPENED THE OUTER STERILE PACKAGE, AND THE SURGEON PROCEEDED WITH A BACKUP OF THE SAME PRODUCT FOR THE PROCEDURE. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23969360 ↗
• MalfunctionMay 13, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY THAT THE SUTURE FRACTURED WHILE THE SURGEON APPLIED TENSION TO THE SUTURE. THE PATIENT DID NOT RETAIN ANY FOREIGN MATTER FROM THE DEVICE. THERE WAS NO REPORTED SERIOUS INJURY. A DELAY OF APPROXIMATELY 15 MINUTES WAS RECORDED. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22009149 ↗
• MalfunctionSep 1, 2023Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT DURING THE SURGERY, A FOREIGN SUBSTANCE WHICH LOOKS LIKE A HAIR WAS ATTACHED TO THE STERILE POUCH. THEREFORE, THE SURGEON USED A BACKUP PRODUCT FOR THE SURGERY. THERE WAS NO PATIENT INJURY AS A RESULT OF THE MALFUNCTION. NO FURTHER INFORMATION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17669530 ↗
• InjuryJul 19, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SURGERY FOR AN ACROMIOCLAVICULAR JOINT DISLOCATION. SUBSEQUENTLY, THE PATIENT ACROMIOCLAVICULAR JOINT DISLOCATED AGAIN THE NEXT DAY DUE TO AN UNKNOWN REASON. THE PATIENT WAS REVISED TWO MONTHS LATER.

  Patient problems: Joint Dislocation

  MAUDE report 17350980 ↗
• InjuryJul 3, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE SUTURE FROM ZIPTIGHT AC BROKE DURING 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 17247937 ↗
• MalfunctionApr 12, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16724525 ↗
• InjuryDec 3, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION APPROXIMATELY ONE AND A HALF (1.5) WEEKS POST-IMPLANTATION AFTER THE SUTURE WAS DISCOVERED TO BE BROKEN. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12923898 ↗
• MalfunctionJan 9, 2020Mechanical Jam; Mechanical Jam

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9568389 ↗
• MalfunctionJan 9, 2020Mechanical Jam; Mechanical Jam

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9568388 ↗

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-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