Z-1988-2015Class II

Natrelle Re-sterilizable Breast Implant Sizer, Size: 410 cc, Style No. MSZFX410. The product is packaged in a...

Name: Z-1988-2015 Natrelle Re-sterilizable Breast Implant Sizer, Size: 410 cc, Style No. MSZFX410. The product is packaged in a...
Creator: Allergan Inc
Published: 2015-06-08
License: https://open.fda.gov/license/

Allergan / initiated 2015-06-08 / Terminated / root cause: labeling and UDI

FDA source

Allergan Inc began a recall of Natrelle Re-sterilizable Breast Implant Sizer, Size: 410 cc, Style No. MSZFX410. The product is packaged in a thermoformed tray (double sterile barrier) and... on 2015-06-08. FDA classified it as Class II and gives the reason as "Allergan is recalling the NATRELLE 410cc Re-Sterilizable Breast Implant Sizer because the expired product was shipped to the user level". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1988-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-08
Posted: 2015-07-07
Terminated: 2015-12-16
Recalling firm: Allergan
Product: Natrelle Re-sterilizable Breast Implant Sizer, Size: 410 cc, Style No. MSZFX410. The product is packaged in a thermoformed tray (double sterile barrier) and enclosed in a labeled carton.
Product code: MRD Mammary Sizer
Reason for recall: Allergan is recalling the NATRELLE 410cc Re-Sterilizable Breast Implant Sizer because the expired product was shipped to the user level.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: A recall letter dated 6/8/15 was sent to all customers who received the NATRELLE 410 cc Re-Sterilizable Breast Implant Sizer. 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. On June 12, 2015, Actavis sent follow up letters to customers to include one additional serial number.
Quantity in commerce: 9 units
Distribution: CA, IN, MO, NJ, VA
Product codes and lots: Lot # Serial # Style #: 1703043, 14124459, MSZFX410; 1708499, 14164655, MSZFX410; 1801072, 14768661, MSZFX410; 1819375, 14905528, MSZFX410; 1819377, 14911183, MSZFX410; 1819377, 14911197, MSZFX410; 1819377, 14911180, MSZFX410; 1819378, 14907262, MSZFX410; 1819378, 14907266, MSZFX410.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1988-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1988-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-15	2015-07-07

Product code MRD

K831566UnclassifiedCui Mammary Prothesis SizerCox-Uphuff Intl. / cleared 1983-08-12

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)