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U.S. Department of Health and Human Services

Class 2 Device Recall Straumann Bone Level Tapered Implant

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  Class 2 Device Recall Straumann Bone Level Tapered Implant see related information
Date Initiated by Firm September 19, 2014
Date Posted October 23, 2014
Recall Status1 Terminated 3 on March 13, 2015
Recall Number Z-0117-2015
Recall Event ID 69379
510(K)Number K140878  
Product Classification Implant, endosseous, root-form - Product Code DZE
Product Straumann Bone Level Tapered Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim
Article Number: 021 .5308

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.
Code Information Lot number: GY030 Exp. 2019-04
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		 Assembled with Narrow Connect (NC) transfer piece instead of Regular Connect (RC)
FDA Determined
Cause 2		 Packaging process control
Action Strauman notified consignees of this Field Corrective Action by letter dated September 19, 2014 and delivered via hand by Straumann Representative. Accounts are requested to return inventory. Contact (978) 747-2514 for assistance.
Quantity in Commerce 6 units
Distribution US Distribution in states of: FL and MA.
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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