FDA Medical Device Recalls (openFDA)
Inamed Corp: McGhan Style 40, Round Breast Implant, Standard Projection, Silicone-filled Smooth INTRASHIEL Barrier Catalog Numbers: 25-40401 25-40461 25-40501 25-40561
- Recall number
- Z-0006-04
- Recalling firm
- Inamed Corp
- Product
- McGhan Style 40, Round Breast Implant, Standard Projection, Silicone-filled Smooth INTRASHIEL Barrier Catalog Numbers: 25-40401 25-40461 25-40501 25-40561
- Status
- Terminated
- Initiated
- 2003-09-12
- Posted
- 2003-10-15
- Terminated
- 2012-03-07
- Reason
- 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.
- Root cause
- Other
- 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.
- Quantity
- 694
- Distribution
- Nationwide and Canada.
- Lot, serial or model codes
- Serial numbers are too numerous to include.
- 510(k) numbers
- not on file
- PMA numbers
- ["P910044"]
- Product code
- FTR
- Firm FEI
- 2024601
- Firm city
- Goleta
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28