ToggleLoc With Ziploop Inline 110005087Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
Quick summary
This is the Biomet ToggleLoc with ZipLoop, an implant used to fix tissue to bone during ACL surgery. It has 24 adverse event reports, with no deaths and 2 injuries. Most reports describe the device's loop or thread breaking during fixation, sometimes requiring a different product to finish the procedure. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00880304567634), received between Nov 26, 2019 and Sep 10, 2025 — classified as 2 injuries, 21 malfunctions.
The most frequently reported specific device problem is “Fracture” (17 reports).
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.
Reports received per month
Most reported problems
Device problems
- Fracture17
- Migration or Expulsion of Device3
- Detachment of Device or Device Component1
- Difficult or Delayed Positioning1
- Incomplete or Missing Packaging1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- No Clinical Signs, Symptoms or Conditions20
- Unspecified Tissue Injury2
- Failure of Implant1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 10, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A PROCEDURE, THE TREAD OF ACL ZIP-LOOP INLINE BROKE DURING PULL-UP WHILE BEING FIXATED. 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 23018813 ↗MalfunctionApr 1, 2025Fracture; Fracture
IT WAS REPORTED THAT WHILE THE SURGEON PULLED THE BUTTON THE THREAD FRACTURED, CAUSING THE SURGEON TO NOT BE ABLE TO USE THE PRODUCT. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21740033 ↗MalfunctionNov 14, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20683155 ↗MalfunctionApr 30, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19212171 ↗MalfunctionApr 4, 2024Incomplete or Missing Packaging; Incomplete or Missing Packaging
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19044871 ↗MalfunctionMar 18, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING AN INITIAL PROCEDURE, THE BUTTON LOOP FRACTURED AWAY FROM THE FEMUR DURING FIXATION. THE CORRECT SURGICAL TECHNIQUE WAS USED. NO COMPLICATIONS, INJURIES, OR SURGICAL INTERVENTIONS WERE REPORTED DUE TO THIS MALFUNCTION. THE CASE WAS COMPLETED WITHOUT ANY ADVERSE OUTCOMES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18923743 ↗MalfunctionMar 13, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18894461 ↗MalfunctionMar 7, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18855808 ↗MalfunctionMar 4, 2024Fracture; Fracture
IT WAS REPORTED, THAT THE IMPLANT FRACTURED, DURING THE PROCEDURE. NO ADVERSE EVENTS HAVE BEEN REPORTED, AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18825108 ↗MalfunctionJan 11, 2024Fracture; Fracture
IT WAS REPORTED THAT THE BUTTON LOOP OF THE TOGGLELOC DEVICE WAS FRACTURED DURING FIXATION. 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 18493073 ↗MalfunctionDec 19, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18354626 ↗MalfunctionSep 25, 2023Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED THAT THE TOGGLELOC WITH ZIPLOOP INLINE PULLED OR CUT OUT THE GRAFT WHILE PULLING OF THE THREAD DURING THE SURGERY. NO ADVERSE EVENT HAS BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17807518 ↗MalfunctionSep 25, 2023Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED THAT THE TOGGLELOC WITH ZIPLOOP INLINE PULLED OR CUT OUT THE GRAFT WHILE PULLING OF THE THREAD DURING THE SURGERY. NO ADVERSE EVENT HAS BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17807510 ↗MalfunctionAug 2, 2023Fracture; Fracture
IT WAS REPORTED BY THE SURGEON THAT ONE OF THE FOUR SUTURE STRANDS RIPPED OFF IN THE PROCESS OF PASSING THE TOGGLELOC AND GRAFT THROUGH THE TUNNELS. NO ADVERSE EVENT HAS BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17442489 ↗InjuryJun 27, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Unspecified Tissue Injury
MAUDE report 17209176 ↗MalfunctionJun 13, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17119197 ↗MalfunctionMay 25, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17001619 ↗MalfunctionMay 24, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16992710 ↗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 14947430 ↗InjuryJun 15, 2022Migration or Expulsion of Device; Loosening of Implant Not Related to Bone-Ingrowth; Migration or Expulsion of Device; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE SURGEON FIXED THE TENDON GRAFT AND WHEN CHECKING THE GRAFT FIXATION, HE NOTICED THAT THE GRAFT WAS LOOSE AND THE BUTTON CAME OUT AND GOT STUCK IN THE FEMORAL TUNNEL. AN OSTEOTOMY WAS PLANNED TO REMOVE THE BUTTON BY THE SURGEON.
Patient problems: Failure of Implant; Unspecified Tissue Injury
MAUDE report 14700243 ↗MalfunctionSep 23, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12518966 ↗MalfunctionMar 19, 2021Fracture; Fracture
IT WAS REPORTED THAT A KNEE ARTHROSCOPY WAS PERFORMED AND DURING CINCHING, THE SUTURE FRACTURED FROM THE BUTTON. NO ADVERSE EVENT HAS BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11526910 ↗MalfunctionNov 26, 2019Difficult or Delayed Positioning; Difficult or Delayed Positioning
UPON REASSESSMENT OF THE REPORTED EVENT IT WAS DETERMINED THAT THE EVENT IS NO LONGER CONSIDERED AS REPORTABLE. THE INITIAL REPORT WAS SUBMITTED IN ERROR AND NEEDS TO BE VOIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9378304 ↗
Other STAPLE, FIXATION, BONE devices
- N/A StandardSynthes GmbH · Staple, Fixation, Bone2 recalls16 reports
- GII QUICKANCHOR ETHIBOND 212034Medos International Sàrl · STAPLE, FIXATION, BONE98 reports
- GII QUICKANCHOR ORTHOCORD 222983Medos International Sàrl · STAPLE, FIXATION, BONE94 reports
- Speed SE-0910Synthes GmbH · Staple, Fixation, Bone1 recall24 reports
- Speed Shift SE-2020-10Synthes GmbH · Staple, Fixation, Bone1 recall10 reports
- Lapiplasty SpeedPlate SK50Treace Medical Concepts, Inc. · Staple, Fixation, Bone59 reports
- LUPINE ORTHOCORD 210709Depuy Mitek, LLC · STAPLE, FIXATION, BONE56 reports
- Speed SE-1512Synthes GmbH · Staple, Fixation, Bone1 recall6 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.