McGhan Style 468-380cc Saline-Filled BIOCELL textured Breast Implants, Catalog Number:468-380
FDA device recall Z-0336-06 · posted 2005-12-31 · Terminated
Recall details
- Recalling firm
- Inamed Corp
- Reason for recall
- Two lots of products were mislabeled; a lot of twenty Style 468 Breast Implants and a lot of twenty Style 163 Breast Implants. In error, the labels for these two lots were switched during packaging. As a result, a total of 40 devices were mislabeled.
- Action taken
- On Wednesday, 14-December-2005, Inamed began calling affected customers to notify them of the voluntary recall. At the end of business on Wednesday, 14-December-2005, Inamed distributed Recall Notification Letters via Federal Express overnight mail directly to affected customers.
- Root cause
- Other
- Status
- Terminated
- Product code
- FWM
- Quantity affected
- 18
- Distribution
- Nationwide
- Date initiated
- 2005-12-14
- Date posted
- 2005-12-31
- Date terminated
- 2007-01-29
- Location
- Goleta, CA
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