Z-0812-2015Class II

ASTS-LG1212: Anterior Lumbar Interbody Fusion Spine Truss System (orthopedic implant) Large, 12 degrees...

Name: Z-0812-2015 ASTS-LG1212: Anterior Lumbar Interbody Fusion Spine Truss System (orthopedic implant) Large, 12 degrees...
Creator: 4-Web Inc.
Published: 2014-09-29
License: https://open.fda.gov/license/

4WEB Inc. / initiated 2014-09-29 / Terminated / root cause: labeling and UDI

FDA source

4-Web Inc. began a recall of ASTS-LG1212: Anterior Lumbar Interbody Fusion Spine Truss System (orthopedic implant) Large, 12 degrees lordosis, 12 mm height and ASTS-LG0612: Anterior Lumbar... on 2014-09-29. FDA classified it as Class II and gives the reason as "Product is mislabeled". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0812-2015
Classification: Class II
Status: Terminated
Initiated: 2014-09-29
Posted: 2014-12-16
Terminated: 2016-06-27
Recalling firm: 4WEB Inc.
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
Product code: MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Reason for recall: Product is mislabeled.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: 4Web Medical sent an Urgent Medical Device Recall letter dated November 5, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm does not require any action to be performed by the consignees.The firm plans to label the remaining recalled lot not distributed as , "samples". Please contact 4Web Customer Service for questions and support. Phone: (1-800) 285-7090 Hours: Monday through Friday, 8:00am to 5:00pm Central Standard time.
Quantity in commerce: 35 units
Distribution: US Distribution including the states of TX, MT, DC, CA, IL, and MD.
Product codes and lots: Model ASTS-LG1212 serial numbers: AL23BA064, AL23BA065, AL23BA066, AL23BA067, AL23BA068, AL23BA069, AL23BA070, AL23BA071, AL23BA072, AL23BA073, AL23BA074, AL23BA075, AL23BA076, AL23BA077, AL23BA078, AL23BA079, AL23BA080, AL23BA081, AL23BA082, AL23BA083, AL23BA084, AL23BA085, AL23BA086, AL23BA087, AL23BA088, AL23BA089, AL23BA090, AL23BA091, AL23BA092, AL23BA093 Model ASTS-LG0612 serial numbers: AL13BA050, AL13BA051, AL13BA052, AL13BA053, AL13BA054, AL13BA055, AL13BA056, AL13BA057, AL13BA058, AL13BA059, AL13BA060, AL13BA061, AL13BA062, AL13BA063, AL13BA064, AL13BA065, AL13BA066, AL13BA067, AL13BA068, AL13BA069, AL13BA070, AL13BA071, AL13BA072, AL13BA073, AL13BA074, AL13BA075, AL13BA076

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0812-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0812-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-16

Product code MAX

K112316Class II4-Web Alif Spinal Truss System (Sts)4-Web, Inc. / cleared 2011-12-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)