McGhan Round Breast Implant, Saline-Filled BIOCELL textured. McGhan Shaped Breast Implant Saline Filled BIOCELL textured.
FDA Recall Z-1216-03 · Posted 2003-09-11
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Recalling FirmInamed Corp
Recall StatusTerminated
Product CodeFWM
Date Initiated2003-08-01
Date Terminated2003-09-10
Product Quantity4
Reason for Recall
Labeling mixup.
Firm Action
Implants were requested back by telephone. They were returned at the firm''s expense. Recall is complete.
Root Cause
Other
Distribution Pattern
Tenessee.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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