ASTS-LG1212: Anterior Lumbar Interbody Fusion Spine Truss System — Class II medical device recall Z-0812-2015
Terminated recall by 4-Web Inc., reported 2014-12-24, distributed in CA, DC, IL, MD, MT, TX. Product is mislabeled.
| Recall number | Z-0812-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | 4-Web Inc., Frisco, TX, United States |
| Recall initiated | 2014-09-29 |
| Classified | 2014-12-16 |
| Reported by FDA | 2014-12-24 |
| Terminated | 2016-06-27 |
| Distributed | CA, DC, IL, MD, MT, TX |
| Quantity | 35 units |
| Reason classes | labeling |
| 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 and 32 more |
| Model numbers | ASTS-LG0612, ASTS-LG1212 |
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 for recall
Product is mislabeled.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0812-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.