TOGGLELOC XL WITH ZIPLOOP INLINE 110005090Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00880304567658), received between Feb 6, 2020 and Jan 30, 2026 — classified as 4 malfunctions.

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

3 other recalls cover devices cleared under the same FDA submission (K130033, K173278); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2026Fracture

  IT WAS REPORTED THAT DURING ARTHROSCOPY WITH ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION, THE FIXATION DEVICE¿S THREAD BROKE INTRA-OPERATIVELY; A SECOND FIXATION DEVICE WAS THEN USED, AND ITS THREADS TORE AGAIN, AND THE PROCEDURE WAS ULTIMATELY COMPLETED USING A THIRD FIXATION DEVICE SUCCESSFULLY. BOTH MALFUNCTIONING DEVICES WERE RECOVERED, AND NO PARTS REMAINED IN THE PATIENT. THERE WERE NO KNOWN IMPACTS OR CONSEQUENCES TO THE PATIENT, AND THE PROCEDURE WAS COMPLETED. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24222161 ↗
• MalfunctionJan 30, 2026Fracture

  IT WAS REPORTED THAT DURING ARTHROSCOPY WITH ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION, THE FIXATION DEVICE¿S THREAD BROKE INTRA-OPERATIVELY; A SECOND FIXATION DEVICE WAS THEN USED, AND ITS THREADS TORE AGAIN, AND THE PROCEDURE WAS ULTIMATELY COMPLETED USING A THIRD FIXATION DEVICE SUCCESSFULLY. BOTH MALFUNCTIONING DEVICES WERE RECOVERED, AND NO PARTS REMAINED IN THE PATIENT. THERE WERE NO KNOWN IMPACTS OR CONSEQUENCES TO THE PATIENT, AND THE PROCEDURE WAS COMPLETED. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24222155 ↗
• MalfunctionJul 7, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE LOOPS OF THE TOGGLELOC IMPLANT BROKE WHEN TIGHTENING THEM. THE PRODUCT WILL NOT BE RETURNED AS THEY HAD TO BREAK IT WITH A WIRE CUTTER. THE EVENT CAUSED A 10-15 MINUTE DELAY IN SURGERY. THIS TIME TAKES INTO ACCOUNT THE BREAKAGE, EXTRACTION AND IMPLEMENTATION OF A NEW LOOP FROM ANOTHER MANUFACTURER. THERE WAS NO ADDITIONAL SURGERY, NO CONTRIBUTING CONDITION, AND THE SURGICAL TECHNIQUE WAS FOLLOWED. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14947515 ↗
• MalfunctionFeb 6, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE TOGGLELOC XL FRACTURED DURING A PROCEDURE. THE EVENT TOOK PLACE AT THE END OF THE SURGERY, AFTER OBTAINING THE DESIRED TENSION OF THE ACL GRAFT FOR THE SILVA TECHNIQUE IN THE TIBIAL TUNNEL. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9677653 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K130033, K173278. 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