McGhan Style 40, Round Breast Implant, Standard Projection, Silicone-filled Smooth INTRASHIEL Barrier Catalog Numbers: 2
FDA device recall Z-0006-04 · posted 2003-10-15 · Terminated
Recall details
- Recalling firm
- Inamed Corp
- 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 taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- FTR
- Quantity affected
- 694
- Distribution
- Nationwide and Canada.
- Date initiated
- 2003-09-12
- Date posted
- 2003-10-15
- Date terminated
- 2012-03-07
- Location
- Goleta, CA
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