ASTS-LG1212: Anterior Lumbar Interbody Fusion Spine recall: Labeling Error
ASTS-LG1212: Anterior Lumbar Interbody Fusion Spine Truss System (orthopedic implant) Large, 12 degrees lordosis, 12 mm height and ASTS-LG0612…
Why was ASTS-LG1212: Anterior Lumbar Interbody Fusion Spine recalled?
Product is mislabeled.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- ASTS-LG1212: Anterior Lumbar Interbody Fusion Spine Truss System (orthopedic implant) Large, 12 degrees lordosis, 12 mm height and ASTS-LG0612…
- Recalling firm
- 4-Web Inc.
- Quantity
- 35 units
- Distribution
- US Distribution including the states of TX, MT, DC, CA, IL, and MD.
- Recall date
- December 24, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)