Recall Z-0812-2015 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
4-Web Inc.
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
| Date | Dec 16, 2014 (initiated Sep 29, 2014) |
| Status | Terminated |
| Reason | Product is mislabeled. |
| Root cause | Labeling mix-ups |
| Action | 4Web Medical sent an Urgent Medical Device Recall letter dated November 5, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm does not require any action to be performed by the consignees.The firm plans to label the remaining recalled lot not distributed as , "samples". Please contact 4Web Customer Service for questions and support. Phone: (1-800) 285-7090 Hours: Monday through Friday, 8:00am to 5:00pm Central Standard time. |
| Quantity | 35 units |
| Distribution | US Distribution including the states of TX, MT, DC, CA, IL, and MD. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112316 | 4-WEB ALIF SPINAL TRUSS SYSTEM (STS) 4-Web, Inc., Dec 14, 2011 |