Devices

Device Recall Natrelle CUI Tissue Expander

Model / Serial
Serial No. (Lot No.) VE7507 (5F075-OEM), VE9273 (6H009-OEM), VF4561 (09H024-OEM), VF5340 (10A115-OEM), VE9272 (6H009-OEM), VF3627 (09E231-OEM), VE9117 (6F158-OEM), VF1201 (7K195-OEM), VF5396 (10A182-OEM), VF5341 (10A115-OEM), VF4923 (09J052-OEM), VF1420 (7L085-OEM), VF1327(7L043-OEM), VE7508 (5F075-OEM), VF1427 (7L085-OEM), VE9274 (6H009-OEM).
Product Classification
General and Plastic Surgery Devices
Device Class
Unclassified
Implanted device?
Yes
Distribution
US in the state of Canada
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.
Manufacturer
Allergan Inc
1 Event
- Recall of Device Recall Natrelle CUI Tissue Expander

Manufacturer

Allergan Inc

Manufacturer Address
Allergan Inc, 2525 Dupont Dr, Irvine CA 92612-1531
Manufacturer Parent Company (2017)
Allergan Public Limited Company
Source
USFDA

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