FDA-Device2015-07-29Class II
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.
Allergan Inc
Hazard
Allergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the products shipped were beyond the shelf life.
Sold states
US in the state of Canada
Affected count
23 units total (16 units in US)
Manufactured in
2525 Dupont Dr, N/A, Irvine, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2104-2015Don't want to check this manually?
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