FDA-Device2014-12-24Class II
ASTS-LG1212: Anterior Lumbar Interbody Fusion Spine Truss System (orthopedic implant) Large, 12 degrees lordosis, 12 mm height and ASTS-LG0612: Anterior Lumbar Interbody Fusion Spine Truss System (orthopedic implant) Large, 6 degrees lordosis, 12 mm height
4-Web Inc.
Hazard
Product is mislabeled.
Sold states
US Distribution including the states of TX, MT, DC, CA, IL, and MD.
Affected count
35 units
Manufactured in
6710 Reseach Rd., Suite #219, Frisco, TX, United States
Products
ASTS-LG1212: Anterior Lumbar Interbody Fusion Spine Truss System (orthopedic implant) Large, 12 degrees lordosis, 12 mm height and ASTS-LG0612: Anterior Lumbar Interbody Fusion Spine Truss System (orthopedic implant) Large, 6 degrees lordosis, 12 mm height
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0812-2015Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief