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Terminated

McGhan Style 40, Round Breast Implant, Standard Projection, Silicone-filled Smooth INTRASHIEL Barrier Catalog Numbers: 25-40401 25-40461 25-40501 25-40561

FDA Recall Z-0006-04 · Posted 2003-10-15

Recalling FirmInamed Corp
Recall StatusTerminated
Product CodeFTR
Date Initiated2003-09-12
Date Terminated2012-03-07
Product Quantity694

Reason for Recall

The 400cc, 460cc, 500cc and 560cc sizes of the McGhan Style 40 Silicone-filled Breast Implants were manufactured using one size smaller shells than required.

Firm Action

Recall was by letter to surgeons on 9/12/2003 which ask for return of unimplanted devices and an accounting of what is to be returned.

Root Cause

Other

Distribution Pattern

Nationwide and Canada.

Official Source

View FDA Recall →

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

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