Z-1216-03

McGhan Round Breast Implant, Saline-Filled BIOCELL textured. McGhan Shaped Breast Implant Saline Filled...

Name: Z-1216-03 McGhan Round Breast Implant, Saline-Filled BIOCELL textured. McGhan Shaped Breast Implant Saline Filled...
Creator: Inamed Corp
Published: 2003-08-01
License: https://open.fda.gov/license/

Allergan / initiated 2003-08-01 / Terminated / root cause: labeling and UDI

FDA source

Inamed Corp began a recall of McGhan Round Breast Implant, Saline-Filled BIOCELL textured. McGhan Shaped Breast Implant Saline Filled BIOCELL textured on 2003-08-01. The reason FDA records is "Labeling mixup". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1216-03
Status: Terminated
Initiated: 2003-08-01
Posted: 2003-09-11
Terminated: 2003-09-10
Recalling firm: Allergan
Product: McGhan Round Breast Implant, Saline-Filled BIOCELL textured. McGhan Shaped Breast Implant Saline Filled BIOCELL textured.
Product code: FWM Prosthesis, Breast, Inflatable, Internal, Saline
Reason for recall: Labeling mixup.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Implants were requested back by telephone. They were returned at the firm''s expense. Recall is complete.
Quantity in commerce: 4
Distribution: Tenessee.
Product codes and lots: 27-168391 27-363170LF

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)