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
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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
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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 |
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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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510(K) Database | 510(K)s with Product Code = DZE
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