FDA Medical Device Recalls (openFDA)
Inamed Corp: McGhan Round Breast Implant, Saline-Filled BIOCELL textured. McGhan Shaped Breast Implant Saline Filled BIOCELL textured.
- Recall number
- Z-1216-03
- Recalling firm
- Inamed Corp
- Product
- McGhan Round Breast Implant, Saline-Filled BIOCELL textured. McGhan Shaped Breast Implant Saline Filled BIOCELL textured.
- Status
- Terminated
- Initiated
- 2003-08-01
- Posted
- 2003-09-11
- Terminated
- 2003-09-10
- Reason
- Labeling mixup.
- Root cause
- Other
- Action
- Implants were requested back by telephone. They were returned at the firm''s expense. Recall is complete.
- Quantity
- 4
- Distribution
- Tenessee.
- Lot, serial or model codes
- 27-168391 27-363170LF
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FWM
- 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