Medical Device Recall: Z-0006-04

FDA Recalls dataset · Firm: N/A · Status: Terminated

Recall Action Class: N/A Date Initiated: 2003-09-12 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0006-04.

Recall Res Number
Z-0006-04
Recalling Firm / Manufacturer
N/A
FEI Number
2024601
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2003-09-12
Date Posted
2003-10-15
Date Terminated
2012-03-07
Product Code
FTR
Event Number
27294
Product Quantity
694
Product Description McGhan Style 40, Round Breast Implant, Standard Projection, Silicone-filled Smooth INTRASHIEL Barrier Catalog Numbers: 25-40401 25-40461 25-40501 25-40561
Reason for Recall The 400cc, 460cc, 500cc and 560cc sizes of the McGhan Style 40 Silicone-filled Breast Implants were manufactured using one size smaller shells than required.
Action Details Recall was by letter to surgeons on 9/12/2003 which ask for return of unimplanted devices and an accounting of what is to be returned.
Distribution Pattern Nationwide and Canada.
Code Information / Serial Numbers Serial numbers are too numerous to include.

Related Establishments / Registrations

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