Recall Z-1265-2007 ยท LZK Implant, Malar
Spectrum Designs Inc
Spectrum Designs Medical Anatomical Chin Implant; Catalog Number 250-134S; Lot # 31140; Serial Numbers BAHO45 through BAH144
| Date | Jul 24, 2007 |
| Status | Terminated |
| Reason | Mispackaging/Mislabeing: a portion of the lot may be labeled as containing nasal implants |
| 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 | 100 |
| Distribution | Nationwide: California and China |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K944164 | MENISCUS CHIN IMPLANT Spectrum Designs, Inc., Nov 4, 1994 |