Z-2104-2015Class II

Natrelle CUI Series Tissue Expanders

Name: Z-2104-2015 Natrelle CUI Series Tissue Expanders
Creator: Allergan Inc
Published: 2015-06-18
License: https://open.fda.gov/license/

Allergan / initiated 2015-06-18 / Terminated

FDA source

Allergan Inc began a recall of Natrelle CUI Series Tissue Expanders. Product Usage: Natrelle CUI Series Tissue Expander has been designed for temporary implantation to develop a skin flap... on 2015-06-18. FDA classified it as Class II and gives the reason as "Allergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the products shipped were beyond the shelf life". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2104-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-18
Posted: 2015-07-18
Terminated: 2015-12-16
Recalling firm: Allergan
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.
Product code: LCJ Tissue Expander And Accessories
Reason for recall: Allergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the products shipped were beyond the shelf life.
FDA 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 2, 8am-5pm, PST. Customers with adverse events/product complaints are instructed to call (800) 624-4261, option 3, 8am-5pm CST.
Quantity in commerce: 23 units total (16 units in US)
Distribution: US in the state of Canada
Product codes and lots: 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).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2104-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2103-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-17
Z-2104-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-17

Product code LCJ

K865056UnclassifiedCui Tissue Expander Versafil(tm) Tissue ExpanderCox-Uphuff Intl. / cleared 1987-05-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)