Recall Z-2104-2015 ยท LCJ Tissue Expander And Accessories
Allergan Inc
Natrelle CUI Series Tissue Expanders. Product Usage: Natrelle CUI Series Tissue Expander has been designed for temporary implantation to develop a skin flap. The device is used for reconstructive correction of a defect or to provide cover for a prosthetic implant. The CUI Tissue Expander consists of a silicone elastomer envelope and a remote injection port.
| Date | Jul 18, 2015 (initiated Jun 18, 2015) |
| Status | Terminated |
| Reason | Allergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the products shipped were beyond the shelf life. |
| Root cause | Incorrect or no expiration date |
| Action | A recall letter will be sent on 6/18/15 to all customers who received the NATRELLE 133 and CUI series tissue expanders. The letter provides the problem identified and the action to be taken. Customers are instructed to contact GENCO Pharmaceutical Services if the recall actions on the recall letter are unclear. For product returns, customers are instructed to contact GENCO at (877) 319-8966, 7am to 5pm CST. Customers with credit/reimbursements are instructed to contact Allergan at (800) 811-4148, 7am to 5pm PST. Customers with medical inquiries are instructed to contact (800) 433-8871, option |
| Quantity | 23 units total (16 units in US) |
| Distribution | US in the state of Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K865056 | CUI TISSUE EXPANDER VERSAFIL(TM) TISSUE EXPANDER Cox-Uphuff Intl., May 22, 1987 |