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U.S. Department of Health and Human Services

Class 2 Device Recall Silhouette Malar Implant

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  Class 2 Device Recall Silhouette Malar Implant see related information
Date Initiated by Firm June 15, 2007
Date Posted August 29, 2007
Recall Status1 Terminated 3 on March 07, 2012
Recall Number Z-1206-2007
Recall Event ID 38898
510(K)Number K944165  
Product Classification Malar Implant - Product Code LZK
Product Spectrum Designs Medical Anatomical I (Silhouette) Malar Facial Implant, Catalog Number 120-224S.
Code Information Lot number 30838, serial numbers BAE256 through BAE275, manufactured June, 2006. Expiration date is five years from date of manufacture. 
Recalling Firm/
Manufacturer		 Spectrum Designs Inc
6387 B Rose Lane
Carpinteria CA 93013
For Additional Information Contact Jim Dishman
805-684-7678
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 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 in Commerce 15 pairs (left/right)
Distribution Nationwide.
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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