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Terminated

McGhan Style 163-360cc Saline-Filled BIOCELL textured Breast Implants, Catalogue Number :163-360

FDA Recall Z-0337-06 · Posted 2005-12-31

Recalling FirmInamed Corp
Recall StatusTerminated
Product CodeFWM
Date Initiated2005-12-14
Date Terminated2007-01-29
Product Quantity2

Reason for Recall

Two lots of products were mislabeled; a lot of twenty Style 468 Breast Implants and a lot of twenty Style 163 Breast Implants. In error, the labels for these two lots were switched during packaging. As a result, a total of 40 devices were mislabeled.

Firm Action

On Wednesday, 14-December-2005, Inamed began calling affected customers to notify them of the voluntary recall. At the end of business on Wednesday, 14-December-2005, Inamed distributed Recall Notification Letters via Federal Express overnight mail directly to affected customers.

Root Cause

Other

Distribution Pattern

Nationwide

Official Source

View FDA Recall →

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

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