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U.S. Department of Health and Human Services

Class 2 Device Recall Tapered SwissPlus Implant System

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  Class 2 Device Recall Tapered SwissPlus Implant System see related information
Date Initiated by Firm March 20, 2017
Create Date April 14, 2017
Recall Status1 Terminated 3 on November 01, 2017
Recall Number Z-1823-2017
Recall Event ID 76746
510(K)Number K082639  
Product Classification Implant, endosseous, root-form - Product Code DZE
Product Tapered SwissPlus Implant System, Model No. SPB10
Code Information Lot #63498673; UDI: (01) 008890240177 (10) 63498673 (17) 200731
Recalling Firm/
Manufacturer		 Zimmer Dental Inc
1900 Aston Ave
Carlsbad CA 92008-7308
For Additional Information Contact Zimmer Dental Customer Service
800-854-7091
Manufacturer Reason
for Recall		 It was manufactured with the minor diameter of the internal thread that is below specification.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action A customer letter was sent on 3/20/17 to inform customers that Zimmer Biomet is recalling a single lot of the Tapered SwissPlus 3.7mmD Implant, Lot No. 63498673. The letter informs customers that the recall is due to one (1) lot of part number SPB10 (lot 63498673) that was manufactured with the minor diameter of the internal thread below specification. This condition may cause mating issues with some screws. The condition occurs when the screw used has a minor thread diameter that is closer to the maximum allowed diameter (maximum material condition). However, screws closer to the least material condition will still fit into the implant. Customers with questions or concerns are instructed to call the customer call center at 1-800-854-7091 between 8:00 am and 5:00pm EST, Monday through Friday. Customers are also instructed to email to corporatequality.postmarket@zimmerbiomet.com.
Quantity in Commerce 188 units
Distribution Worldwide: ZA, FR, IT, IR
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 = ZIMMER DENTAL INC.
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