CPX4 Breast Tissue Expander 650 cc : Product Usage: Tissue expanders can be used for breast reconstruction after mastect
FDA device recall Z-2781-2016 · posted 2016-09-10 · Terminated
Recall details
- Recalling firm
- Mentor Texas, LP.
- Reason for recall
- The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box.
- Action taken
- Mentor Texas sent an Urgent Field Safety Notice dated August 11, 2016 to customers.via letter and a follow-up with respective Sales Representative visit. The letter identified the affected product, problems and actions to be taken. Customers were informed the firm will credit/replace returned affected products. For questions contact your Sales Representative .
- Root cause
- Employee error
- Status
- Terminated
- Product code
- LCJ
- Quantity affected
- 30 units
- Distribution
- Worldwide Distribution - US Nationwide and the countries of: Germany, UK, and Belgium
- Date initiated
- 2016-08-09
- Date posted
- 2016-09-10
- Date terminated
- 2017-03-08
- Location
- Irving, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERS (K130813) | Mentor Corp. | 2013-04-11 |