Recall Z-0812-2015— 4-Web Inc.

Name: FDA recall Z-0812-2015
Creator: U.S. Food and Drug Administration
Published: 2014-09-29

Class II · Terminated

Class II FDA medical device recall by 4-Web Inc., initiated 2014-09-29, terminated 2016-06-27. It names one FDA 510(k) clearance: K112316. Product: 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. Reason: Product is mislabeled..

Recalling firm: 4-Web Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-09-29
Terminated: 2016-06-27
Firm location: Frisco, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K112316 — 4-WEB ALIF SPINAL TRUSS SYSTEM (STS)4-Web, Inc.·cleared 2011-12-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Product is mislabeled.

Data sourced from openFDA. This site is unofficial and independent of the FDA.