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U.S. Department of Health and Human Services

Class 2 Device Recall Replace Select Tapered Implant

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  Class 2 Device Recall Replace Select Tapered Implant see related information
Date Initiated by Firm June 22, 2016
Create Date July 19, 2016
Recall Status1 Terminated 3 on September 06, 2016
Recall Number Z-2237-2016
Recall Event ID 74486
Product Classification Implant, endosseous, root-form - Product Code DZE
Product Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105
Replace Select Tapered implants are root-form endosseous implants intended to be surgically placed in the bone of the upper and lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function.
Code Information 13030677
Recalling Firm/
Manufacturer		 Nobel Biocare Usa Llc
22715/22725 Savi Ranch Pkwy
Yorba Linda CA 92887
For Additional Information Contact
714-282-4800
Manufacturer Reason
for Recall		 Incorrect top label on an implant package.
FDA Determined
Cause 2		 Labeling False and Misleading
Action Nobel Biocare sent a customer notification letter dated June 23, 2016 to all affected customers to inform them that Nobel Biocare has detected that the lot#13030677 of Replace Select Tapered TiU NP 3.5 x 11.5 mm (product#36105) carries an incorrect top label. The letter informs the customers that the incorrect top label states "Replace NP 3.5 x 11.5 CC" (ie. Conical Connection). The product, Replace Select Tapered TiU NP 3.5 x 11.5 mm, has a Tri-lobe connection. Customers were instructed to complete the attached Quality Message Acknowledgement form. Customer with questions were instructed to contact customer service at 714-282-4808.
Quantity in Commerce 53 units total (33 units in US)
Distribution Worldwide Distribution - US including OR, OH, NY and Internationally to Taiwan and Brazil Non US: Taiwan, SC
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.
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