FDA Device

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

Hazard

Labeling mixup.

What You Should Do

Remedy

Implants were requested back by telephone. They were returned at the firm''s expense. Recall is complete.

Products

McGhan Round Breast Implant, Saline-Filled BIOCELL textured. McGhan Shaped Breast Implant Saline Filled BIOCELL textured.
UPC
27-168391 27-363170LF

Units Affected

4