FDA Medical Device Recalls (openFDA)
Inamed Corp: Style 363 Saline-Filled BIOCELL textured Breast Implants
- Recall number
- Z-0851-05
- Recalling firm
- Inamed Corp
- Product
- Style 363 Saline-Filled BIOCELL textured Breast Implants
- Status
- Terminated
- Initiated
- 2005-05-05
- Posted
- 2005-05-25
- Terminated
- 2011-09-02
- Reason
- Wrong size implant was mislabeled.
- Root cause
- Employee error
- Action
- Firm sent letter by overnite mail on May 5, 2005. Follow-up phone calls were made to confirm reciept. Doctors are to review surgery records and evaluate ammount of saline used to determine the risk for folding occuring and if found a visit by the patient is recommended to further evaluate for folding.
- Quantity
- 6
- Distribution
- WI, TN, TX, NY, AR
- Lot, serial or model codes
- UF6328, UF6330, UF6331, UM5056, UM5057, UM5059
- 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