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Terminated

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

FDA Recall Z-2326-2016 · Posted None

Recalling FirmMentor Texas, LP.
Recall StatusTerminated
Product CodeFTR
Date Initiated2016-07-01
Date Terminated2016-12-09
Product Quantity35 units

Reason for Recall

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

Firm Action

The affected consignees were notified via customer letter on 7/1/16, and a follow-up with respective sales representative via visit.

Root Cause

Labeling mix-ups

Distribution Pattern

Distributed in the states of NY, WI, CA, TX, CO, NC, NJ, OH, TN, RI, and IL.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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