Recall Z-1264-2007 ยท LZK Implant, Malar
Spectrum Designs Inc
Spectrum Designs Medical-Nasal Dorsal Columella Implant, Catalog Number: S400-314S and Lot #31053; Serial Numbers: BAG612 ,BAG6I3, BAG6I4, BAG652, BAG654 and BAG655
| Date | Jul 24, 2007 |
| Status | Terminated |
| Reason | Mispackaging/Mislabeling: a portion of packaged Nasal LOT 31053 contained chin implants instead of the nasal implant. |
| Root cause | Other |
| Action | The firm initiated the recall on 07/24/2007 by contacting the customer (distributor) who filed the original complaint of mislabeling by email. The firm followed-up by sending recall letters (dated July 24, 2007) via FedEx or certified mail with signature confirmation to the one other direct account who received the recalled product on 08/03/2007. Customers were instructed to check their inventory for mislabeled products and call Spectrum at (800)239-6399 to report the number of this product being returned. They were given an address for product return. The firm indicated they will examine retu |
| Quantity | 130 |
| Distribution | Nationwide: California and China |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K944166 | DORSAL COLUMELLA IMPLANT Spectrum Designs, Inc., Nov 4, 1994 |