Date Initiated by Firm |
July 24, 2007 |
Create Date |
June 25, 2015 |
Recall Status1 |
Terminated 3 on July 29, 2011 |
Recall Number |
Z-1264-2007 |
Recall Event ID |
44735 |
510(K)Number |
K944166
|
Product Classification |
Nasal Dorsal Columella Implant, - Product Code LZK
|
Product |
Spectrum Designs Medical-Nasal Dorsal Columella Implant, Catalog Number: S400-314S and Lot #31053; Serial Numbers: BAG612 ,BAG6I3, BAG6I4, BAG652, BAG654 and BAG655 |
Code Information |
Catalog Number: S400-314S and Lot #31053; Serial Numbers: BAG612 ,BAG6I3, BAG6I4, BAG652, BAG654 and BAG655 |
Recalling Firm/ Manufacturer |
Spectrum Designs Inc 6387 Rose Ln Ste B Carpinteria CA 93013-2937
|
For Additional Information Contact |
Jim Dishman 805-684-7678
|
Manufacturer Reason for Recall |
Mispackaging/Mislabeling: a portion of packaged Nasal LOT 31053 contained chin implants instead of the nasal implant.
|
FDA Determined Cause 2 |
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 returned products, and scrap after examination. |
Quantity in Commerce |
130 |
Distribution |
Nationwide: California and China |
Total Product Life Cycle |
TPLC Device Report
|
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = LZK and Original Applicant = SPECTRUM DESIGNS, INC.
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