ZIPTIGHTRecalls & reported problems across all models

We found 2 models of ZIPTIGHT by Biomet Orthopedics, LLC in the FDA's device registry (GUDID). Together they are named in 10 adverse event reports in the FDA's MAUDE database, received between Jan 9, 2020 and Jan 5, 2026 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

ZIPTIGHT recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · Recall details · FDA record ↗

Most reported ZIPTIGHT problems

ZIPTIGHT models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ZIPTIGHT 904834

  FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
  1 recall9 reports
• ZIPTIGHT 904835

  FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
  1 report

Recent ZIPTIGHT adverse event reports

The 10 most recent reports across all models, 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 ↗
• MalfunctionMay 20, 2024Fracture; Fracture

  IT WAS REPORTED IN THE MIDDLE OF THE PROCEDURE WHEN THE IMPLANT WAS OPENED FROM THE PACKAGING, AN INCONSISTENCY WAS NOTED IN THE LOOPS, THE SURGEON GENERATED TENSION TO SEE IF IT COULD BE RESISTANT DURING THE PROCEDURE, BUT IT FRACTURED. THEREFORE, ANOTHER IMPLANT WAS USED TO COMPLETE 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 19350349 ↗
• 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 ↗

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