Medical device recalls Moderate risk

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

Recall date
June 8, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1988-2015
FDA classification
Class II
Brand / firm
Allergan Inc
Sold / distributed
CA, IN, MO, NJ, VA

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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