Z-0851-05

Style 363 Saline-Filled BIOCELL textured Breast Implants

Name: Z-0851-05 Style 363 Saline-Filled BIOCELL textured Breast Implants
Creator: Inamed Corp
Published: 2005-05-05
License: https://open.fda.gov/license/

Allergan / initiated 2005-05-05 / Terminated / root cause: manufacturing process

FDA source

Inamed Corp began a recall of Style 363 Saline-Filled BIOCELL textured Breast Implants on 2005-05-05. The reason FDA records is "Wrong size implant was mislabeled". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0851-05
Status: Terminated
Initiated: 2005-05-05
Posted: 2005-05-25
Terminated: 2011-09-02
Recalling firm: Allergan
Product: Style 363 Saline-Filled BIOCELL textured Breast Implants
Product code: FWM Prosthesis, Breast, Inflatable, Internal, Saline
Reason for recall: Wrong size implant was mislabeled.
Root cause tag: manufacturing process
FDA 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 in commerce: 6
Distribution: WI, TN, TX, NY, AR
Product codes and lots: UF6328, UF6330, UF6331, UM5056, UM5057, UM5059

Product code FWM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)