Artificial Ligament Fixation Device 15MM TI NS ToggleLoc (TM) W/Continuous Maxbraid Polyethylene Suture Loop TO Gal 4V A
FDA device recall Z-0582-2012 · posted 2012-01-11 · Terminated
Recall details
- Recalling firm
- Biomet Sports Medicine
- 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
- Action taken
- 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.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- MBI
- Quantity affected
- 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.
- Date initiated
- 2008-04-24
- Date posted
- 2012-01-11
- Date terminated
- 2011-12-27
- Location
- Ontario, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TITANIUM TOGGLE BUTTON(S) (K033838) | Biomet Manufacturing, Inc. | 2004-02-13 |