Recall Z-2104-2015— Allergan Inc

Name: FDA recall Z-2104-2015
Creator: U.S. Food and Drug Administration
Published: 2015-06-18

Class II · Terminated

Class II FDA medical device recall by Allergan Inc, initiated 2015-06-18, terminated 2015-12-16. It names one FDA 510(k) clearance: K865056. Product: 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.. Reason: Allergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the products shipped were beyond the shelf life..

Recalling firm: Allergan Inc
Classification: Class II
Status: Terminated
Initiated: 2015-06-18
Terminated: 2015-12-16
Firm location: Irvine, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K865056 — CUI TISSUE EXPANDER VERSAFIL(TM) TISSUE EXPANDERCox-Uphuff Intl.·cleared 1987-05-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

Allergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the products shipped were beyond the shelf life.

Data sourced from openFDA. This site is unofficial and independent of the FDA.