FDA Medical Device Recalls (openFDA)
4-Web Inc.: 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
- Recall number
- Z-0812-2015
- Recalling firm
- 4-Web 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
- Status
- Terminated
- Initiated
- 2014-09-29
- Posted
- 2014-12-16
- Terminated
- 2016-06-27
- Reason
- Product is mislabeled.
- 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
- 35 units
- Distribution
- US Distribution including the states of TX, MT, DC, CA, IL, and MD.
- Lot, serial or model codes
- 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
- 510(k) numbers
- K112316
- PMA numbers
- not on file
- Product code
- MAX
- Firm FEI
- 3009189869
- Firm city
- Frisco
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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