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U.S. Department of Health and Human Services

Class 2 Device Recall Artificial Ligament Fixation Device 15mm, 20mm, 25mm, 30mm, & 35mm TI NS Toggleloc; & 7 PE Ziploop

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  Class 2 Device Recall Artificial Ligament Fixation Device 15mm, 20mm, 25mm, 30mm, & 35mm TI NS Toggleloc; & 7 PE Ziploop see related information
Date Initiated by Firm April 24, 2008
Date Posted January 11, 2012
Recall Status1 Terminated 3 on December 27, 2011
Recall Number Z-0582-2012
Recall Event ID 48745
510(K)Number K033838  
Product Classification Fastener, fixation, nondegradable, soft tissue - Product Code MBI
Product Artificial Ligament Fixation Device 15MM TI NS ToggleLoc (TM) W/Continuous Maxbraid Polyethylene Suture Loop TO Gal 4V Alloy/Polyethylene; Artificial Ligament Fixation Device 25MM TI NS ToggleLoc (TM) W/Continuous Maxbraid Polyethylene Suture Loop TO Gal 4V Alloy/Polyethylene; Artificial Ligament Fixation Device 20MM TI NS ToggleLoc (TM) W/Continuous Maxbraid Polyethylene Suture Loop TO Gal 4V Alloy/Polyethylene; Artificial Ligament Fixation Device 30MM TI NS ToggleLoc (TM) W/Continuous Maxbraid Polyethylene Suture Loop TO Gal 4V Alloy/Polyethylene; Artificial Ligament Fixation Device 35MM TI NS ToggleLoc (TM) W/Continuous Maxbraid Polyethylene Suture Loop TO Gal 4V Alloy/Polyethylene; Artificial Ligament Fixation Device #7 PE Ziploop (TM) ToggleLoc (TM).

Toggleloc anchors are indicated for use for fixation of tendons & ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) reconstruction.
Code Information Catalog Number: 904720, 904721, 904722 (x2), 904723, 904724, & 904753 Lot Number Identification: L662080, L662090, L763680 - L662100, L662110, L662120 & L705230
Recalling Firm/
Manufacturer		 Biomet Sports Medicine
4861 E Airport Dr
Ontario CA 91761-7819
For Additional Information Contact
909-390-0356 Ext. 136
Manufacturer Reason
for Recall		 Six sizes of ToggleLoc, Artificial Ligament Fixation Device, have been manufactured with the suture pull hole drilled in the wrong location on the device. The ToggleLoc implant is deployed with a suture that pulls the device through the tunnel. The hole being drilled in the wrong location will orient the device to pass through the tunnel with the angled end of the implant first. This may caus
FDA Determined
Cause 2		 Employee error
Action Biomet Sports Medicine sent an "URGENT MEDICAL DEVICE REMOVAL" notice dated May 15, 2008 to all affected customers. The letter described the product, problem, and the actions to be taken by the customers. The letter instructs customers to locate and discontinue use of the affected product. Customers should contact the firm at 800-535-8692 for questions related to this notice.
Quantity in Commerce 203
Distribution Worldwide Distribution-USA (nationwide) including the states of CA, FL, GA, ID, IL, IN, KS, TX, and WA, and the countries of Australia, Chile, France, Poland, The Netherlands and Turkey.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MBI and Original Applicant = BIOMET MANUFACTURING, INC.
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