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U.S. Department of Health and Human Services

Class 2 Device Recall Straumann Standard Plus Implant

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  Class 2 Device Recall Straumann Standard Plus Implant see related information
Date Initiated by Firm March 12, 2012
Date Posted March 30, 2012
Recall Status1 Terminated 3 on May 31, 2012
Recall Number Z-1351-2012
Recall Event ID 61440
510(K)Number K033922  
Product Classification Accessories, implant, dental endosseous - Product Code NDP
Product Straumann Standard Plus Implant 04.8mm Wide Neck
SLA 10mm
Article Number: 043.652S.

Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. Dental implants are for single-stage or two-stage surgery. Dental implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used.
Code Information Lot No. CW642
Recalling Firm/
Manufacturer		 Straumann USA, LLC
60 Minuteman Rd
Andover MA 01810-1008
For Additional Information Contact SAME
800-448-8168
Manufacturer Reason
for Recall		 Mislabeled: Vial lid label on some of the dental implant vials from this lot incorrectly state 04.8 SP 10 RN instead of 04.8 SP 10 WN
FDA Determined
Cause 2		 Packaging process control
Action Straumann sent a "FIELD CORRECTIVE ACTION NOTICE" dated March 12, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The letter instructs customers to check their inventory for the affected product and to return any affected product to the firm. Additionally, a Customer Confirmation Form was enclosed for customers to complete and return. Contact the firm at 978-747-2514 for questions regarding this notice.
Quantity in Commerce 346 units
Distribution Nationwide Distribution.
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 = NDP and Original Applicant = INSTITUT STRAUMANN AG
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