Spectrum Designs Medical Anatomical I (Silhouette) Malar Facial Implant, Catalog Number 120-224S.
FDA device recall Z-1206-2007 · posted 2007-08-29 · Terminated
Recall details
- Recalling firm
- Spectrum Designs Inc
- Reason for recall
- The product is being recalled because it was discovered the at least one unit in the lot contained a mismatched pair (two rights and no left). Since the lot was produced with equal numbers of pairs, it is assumed that one other unit was packaged with two lefts and no right. This was discovered through a physician complaint.
- Action taken
- The firm initiated the recall on 06/15/2007 by contacting their customers by telephone. The firm followed-up by sending recall letters via FedEx or certified mail with signature confirmation to each direct account who received the recalled product on 06/18/2007.
- Root cause
- Other
- Status
- Terminated
- Product code
- LZK
- Quantity affected
- 15 pairs (left/right)
- Distribution
- Nationwide.
- Date initiated
- 2007-06-15
- Date posted
- 2007-08-29
- Date terminated
- 2012-03-07
- Location
- Carpinteria, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SILHOUETTE MALAR IMPLANT (K944165) | Spectrum Designs, Inc. | 1994-11-04 |