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Terminated

Style 363 Saline-Filled BIOCELL textured Breast Implants

FDA Recall Z-0851-05 · Posted 2005-05-25

Recalling FirmInamed Corp
Recall StatusTerminated
Product CodeFWM
Date Initiated2005-05-05
Date Terminated2011-09-02
Product Quantity6

Reason for Recall

Wrong size implant was mislabeled.

Firm 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.

Root Cause

Employee error

Distribution Pattern

WI, TN, TX, NY, AR

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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