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U.S. Department of Health and Human Services

Class 2 Device Recall Straumann

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  Class 2 Device Recall Straumann see related information
Date Initiated by Firm September 24, 2014
Date Posted November 06, 2014
Recall Status1 Terminated 3 on June 26, 2017
Recall Number Z-0174-2015
Recall Event ID 69454
510(K)Number K121131  
Product Classification Implant, endosseous, root-form - Product Code DZE
Product Straumann Bone Level Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim
Article Number: 021.4308

Product Usage:
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 number: GY256
Recalling Firm/
Manufacturer		 Straumann USA, LLC
60 Minuteman Rd
Andover MA 01810-1008
For Additional Information Contact
800-448-8168
Manufacturer Reason
for Recall		 Product transfer piece was fitted with a Narrow Connect (NC) instead of a Regular Connect (RC)
FDA Determined
Cause 2		 Packaging process control
Action Straumann USA sent a Field Corrective Action Notice letter dated September 24, 2014 and delivered via United Parcel Service. The letter identified the affected product, problem and actions to be taken. Straumann is requesting the return of unused implants. Returns and Customer Confirmation form is to be returned. Contact firm 781-747- 2514.
Quantity in Commerce 111 units
Distribution US 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
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