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Recall Observatory FDA recall evidence

Device 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.

Z-1988-2015

June 08, 2015

Class II

Product summary

Firm
Allergan Inc
Event
Event 71428
Status
Terminated
Classification
Class II
Quantity
9 units
Official record key
device-enforcement:Z-1988-2015

Official wording

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

Code information: 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.

Distribution pattern: CA, IN, MO, NJ, VA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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