The Recall Desk
ModerateFDA (Devices)·Z-0812-2015·Announced 2014-12-24

4-Web Inc. Recalls Mislabeled Anterior Lumbar Spine Truss Systems

4-Web Inc. is recalling 35 units of Anterior Lumbar Interbody Fusion Spine Truss Systems due to product mislabeling. The affected devices were distributed in six US states and DC.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error without reported injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

4-Web Inc. is recalling 35 units of the Anterior Lumbar Interbody Fusion Spine Truss System, specifically models ASTS-LG1212 and ASTS-LG0612. These orthopedic implants are designated as Large, with 12 mm height and either 12 or 6 degrees of lordosis. The recall was initiated because the product is mislabeled.

The affected devices were distributed in the United States, including the states of Texas, Montana, California, Illinois, and Maryland, as well as the District of Columbia. The recall covers specific serial numbers for both models, ranging from AL23BA064 to AL23BA093 for the ASTS-LG1212 and AL13BA050 to AL13BA076 for the ASTS-LG0612.

Healthcare providers and facilities that have received these devices should check their inventory against the provided serial numbers. If the affected units are found, they should be removed from use and returned to 4-Web Inc. in accordance with the recall instructions.

The recalled product

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
Manufacturer
4-Web Inc.
Affected units
35

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed in 6 states: