Biomet Sports Medicine: 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.

Recall number

Z-0582-2012

Recalling firm

Biomet Sports Medicine

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.

Status

Terminated

Initiated

2008-04-24

Posted

2012-01-11

Terminated

2011-12-27

Reason

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

Root cause

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

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.

Lot, serial or model codes

Catalog Number: 904720, 904721, 904722 (x2), 904723, 904724, & 904753 Lot Number Identification: L662080, L662090, L763680 - L662100, L662110, L662120 & L705230

510(k) numbers

["K033838"]

PMA numbers

not on file

Product code

MBI

Firm FEI

1000125597

Firm city

Ontario

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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