Medical device recalls Moderate risk

Mentor Texas, LP. recalls Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction.

Recall date
July 1, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2326-2016
FDA classification
Class II
Brand / firm
Mentor Texas, LP.
Sold / distributed
Distributed in the states of NY, WI, CA, TX, CO, NC, NJ, OH, TN, RI, and IL.

Why it was recalled

The box of 300cc MemoryGel Breast Implant was labeled with null manufacturing and expiration dates.

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

What was recalled

Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction.

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