FDA Medical Device Recalls (openFDA)
Inamed Corp: McGhan Style 468-380cc Saline-Filled BIOCELL textured Breast Implants, Catalog Number:468-380
- Recall number
- Z-0336-06
- Recalling firm
- Inamed Corp
- Product
- McGhan Style 468-380cc Saline-Filled BIOCELL textured Breast Implants, Catalog Number:468-380
- Status
- Terminated
- Initiated
- 2005-12-14
- Posted
- 2005-12-31
- Terminated
- 2007-01-29
- Reason
- 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.
- Root cause
- Other
- 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.
- Quantity
- 18
- Distribution
- Nationwide
- Lot, serial or model codes
- Lot#1121360, Serial#11567825, 11567826, 11567827, 11567828, 11567829, 11567830, 11567832, 11567833, 11567835, 11567836, 11567838, 11567839, 11567840, 11567841, 11567842, & 11567843.
- 510(k) numbers
- not on file
- PMA numbers
- ["P990074"]
- 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