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Natrelle Re-sterilizable Breast Implant Sizer, Size: 410… recallZ-1988-2015 · Allergan Inc · initiated Jun 8, 2015

Class II Terminated All recalls posted in July 2015

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Allergan Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Allergan is recalling the NATRELLE 410cc Re-Sterilizable Breast Implant Sizer because the expired product was shipped to the user level.

FDA root cause category: Error in labeling

What the company is doing

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.

Recall details

Recall number
Z-1988-2015
Recall class
Class II
Status
Terminated
Initiated by the company
Jun 8, 2015
Posted by the FDA
Jul 7, 2015
Recalling firm
Allergan Inc
Quantity
9 units
Product code
MRD
FDA submissions
K831566
Distribution
CA, IN, MO, NJ, VA

Product description

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.

Code information (models, lots, serial numbers)

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.

Other devices under the same FDA submission

21 devices cleared under K831566 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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