Z-0812-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 24, 2014
- Initiation Date
- September 29, 2014
- Termination Date
- June 27, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35 units
Product Description
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.
Distribution Pattern
US Distribution including the states of TX, MT, DC, CA, IL, and MD.
Code Information
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