McGhan Style 468-380cc Saline-Filled BIOCELL textured Breast Implants, Catalog Number:468-380
This recall has been terminated (originally issued December 31, 2005).
- Company
- Inamed Corp
- Recall Initiated
- December 14, 2005
- Posted
- December 31, 2005
- Terminated
- January 29, 2007
- Recall Number
- Z-0336-06
- Quantity
- 18
- Firm Location
- Goleta, CA
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide
Lot / Code Info
Lot#1121360, Serial#11567825, 11567826, 11567827, 11567828, 11567829, 11567830, 11567832, 11567833, 11567835, 11567836, 11567838, 11567839, 11567840, 11567841, 11567842, & 11567843.
Root Cause
Other
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.