ASTS-LG1212: Anterior Lumbar Interbody Fusion Spine Truss System (orthopedic implant) Large, 12 degrees lordosis, 12 mm
FDA device recall Z-0812-2015 · posted 2014-12-16 · Terminated
Recall details
- Recalling firm
- 4-Web Inc.
- Reason for recall
- Product is mislabeled.
- Action taken
- 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.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- MAX
- Quantity affected
- 35 units
- Distribution
- US Distribution including the states of TX, MT, DC, CA, IL, and MD.
- Date initiated
- 2014-09-29
- Date posted
- 2014-12-16
- Date terminated
- 2016-06-27
- Location
- Frisco, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 4-WEB ALIF SPINAL TRUSS SYSTEM (STS) (K112316) | 4-Web, Inc. | 2011-12-14 |