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U.S. Department of Health and Human Services

Class 2 Device Recall Straumann Bone Level Implant

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  Class 2 Device Recall Straumann Bone Level Implant see related information
Date Initiated by Firm July 14, 2016
Create Date August 12, 2016
Recall Status1 Terminated 3 on November 20, 2020
Recall Number Z-2535-2016
Recall Event ID 74799
510(K)Number K150938  
Product Classification Implant, endosseous, root-form - Product Code DZE
Product Straumann Bone Level Implant, ¿ 4.1mm RC, SLA¿ 12mm, TiZr, NTP
Article Number: 021.4512
Code Information Lot Number: LT123
Recalling Firm/
Manufacturer		 Straumann Manufacturing, Inc.
60 Minuteman Rd
Andover MA 01810-1008
For Additional Information Contact SAME
800-448-8168
Manufacturer Reason
for Recall		 Misalignment with the Loxim transfer piece markings, the positioning of the implant will be incorrect for optimal restoration
FDA Determined
Cause 2		 Under Investigation by firm
Action Straumann notified customers via telephone on Thursday, July 14, 2016. Customers with an e-mail address on file were also e-mailed on Friday, July 15, 2016.Straumann notified customers were sent a hard copy letter via UPS on Saturday, July 16, 2016 for delivery on Monday, July 18, 2016. The customers have been notified not to use these implants and to return unused implants to Straumann. The customers that have used the implants have been asked to provide the restorative situation for the implants. Depending on the restorative situation, additional instructions may be necessary to restore the implants.
Quantity in Commerce 33 pieces
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 = DZE and Original Applicant = STRAUMANN USA, LLC
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