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U.S. Department of Health and Human Services

Class 2 Device Recall Spectrum Designs MedicalNasal Dorsal Columella Implant

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  Class 2 Device Recall Spectrum Designs MedicalNasal Dorsal Columella Implant see related information
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
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.
510(K) Database 510(K)s with Product Code = LZK and Original Applicant = SPECTRUM DESIGNS, INC.
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