Recall Z-1206-2007 ยท LZK Implant, Malar
Spectrum Designs Inc
Spectrum Designs Medical Anatomical I (Silhouette) Malar Facial Implant, Catalog Number 120-224S.
| Date | Aug 29, 2007 (initiated Jun 15, 2007) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 15 pairs (left/right) |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K944165 | SILHOUETTE MALAR IMPLANT Spectrum Designs, Inc., Nov 4, 1994 |