McGhan Style 163-360cc Saline-Filled BIOCELL textured Breast Implants, Catalogue Number :163-360
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-0337-06
- Quantity
- 2
- 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#1121514, Serial# 11567927 & 11567935
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.