Brand Name: AFX" Introducer System, Model Number S17-45. Lot Numbers: 1079840, 1079843, 1079844, 1079845. Product Usage:
FDA device recall Z-1436-2013 · posted 2013-06-07 · Terminated
Recall details
- Recalling firm
- Endologix Inc
- Reason for recall
- Endologix, Inc. initiated this voluntary recall of certain lots of Endologix, Inc. due to reports of dilator breakage during clinical procedures.
- Action taken
- Endologix Inc sent an "URGENT-MEDICAL DEVICE RECALL NOTICE" letters dated May 13, 2013 to all affected customers. The letter identified the affected product, reason for recall, and actions to be taken. The letter instructed customers to do not use or further distribute any affected product. The letter instructed customers to share this information with physicians that perform these procedures at the facility. The firm will call to confirm that this device is located at the facility. After confirmation the firm will retrieve the device. For questions call (800) 983-2284.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 53
- Distribution
- Worldwide Distribution - USA Nationwide in the states of: NY, NH, IN, MI, FL and NJ and in the countries of: Europe and Latin America.
- Date initiated
- 2013-05-13
- Date posted
- 2013-06-07
- Date terminated
- 2013-08-19
- Location
- Irvine, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AFX INTRODUCER SYSTEM (K120212) | Endologix, Inc. | 2012-02-09 |