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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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.
- Hazard
- 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
Related recalls
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateK2M Cascadia AN Interbody Implants Recalled for Mislabeled Dimensions
FDA (Devices) · 2021-06-09
- HighK2M Cascadia AN Interbody Lumbar Implants recalled for mislabeled dimensions
FDA (Devices) · 2021-06-09
- HighK2M Cascadia lumbar implants recalled for mislabeled dimensions
FDA (Devices) · 2021-06-09
- HighMedtronic Catalyft LS spinal implant recalled for out-of-specification device dimensions
FDA (Devices) · 2023-07-19
- ModerateBiomet Spine Recalls Solitaire Ti Spacers Due to Mislabeled Lordotic Angle
FDA (Devices) · 2016-04-06
- ModerateOrthofix Pillar SA Ti Spacer System Mislabeled for Anterior Height
FDA (Devices) · 2025-04-02