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U.S. Department of Health and Human Services

Class 3 Device Recall Straumann NC Closure Screw

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  Class 3 Device Recall Straumann NC Closure Screw see related information
Date Initiated by Firm January 10, 2008
Date Posted April 30, 2008
Recall Status1 Terminated 3 on November 06, 2009
Recall Number Z-1037-2008
Recall Event ID 46358
510(K)Number K071585  
Product Classification Precision attachment - Product Code EGG
Product Straumann NC Closure Screw, Titanium, Precision attachment, Article Number: 024.2105.04, Straumann, Andover, MA 01810
Code Information Lot Number: G8677
Recalling Firm/
Manufacturer		 Straumann Usa, Llc
60 Minuteman Rd
Andover MA 01810-1008
Manufacturer Reason
for Recall		 Mislabeled package: Narrow Connection (NC) Closure Screws contain closure screws for the regular connection (RC) bone level implant. The RC closures screw is larger (3.5mm diameter) and therefore, will not fit into the NC implant (3.0mm diameter) narrow connection.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action Consignees were notified by telephone on 1/10/08 followed by an Urgent Device Recall letter on January 10, 2008. The letter instructs users to return any affected product to the firm along with a recall acknowledgement form. For additional information, contact 978-747-2514.
Quantity in Commerce 26 units
Distribution Nationwide Distribution including states of CA, DE, FL, IL, ME, NY, OH, OR, and TX.
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 = EGG and Original Applicant = STRAUMANN USA
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