| Class 2 Device Recall Spline Twist Implant |  |
Date Initiated by Firm | October 01, 2014 |
Date Posted | October 30, 2014 |
Recall Status1 |
Terminated 3 on April 28, 2015 |
Recall Number | Z-0153-2015 |
Recall Event ID |
69392 |
510(K)Number | K093164 |
Product Classification |
Implant, endosseous, root-form - Product Code DZE
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Product | Spline Twist Implant, HA 3.25mmD X 15mmL; Part No. 2135.
Zimmer Dental Spline implant systems are designed for use in edentulous mandibles or maxillae for attachment of complete denture prostheses for immediate or conventional loading, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a free standing single tooth replacement. |
Code Information |
Lot No. 61792330 |
Recalling Firm/ Manufacturer |
Zimmer Dental Inc 1900 Aston Ave Carlsbad CA 92008-7308
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For Additional Information Contact | 760-929-4107 |
Manufacturer Reason for Recall | Zimmer Dental is recalling Tapered Screw-Vent Implants because the incorrect diameter size was printed on the inner vial. |
FDA Determined Cause 2 | Labeling Change Control |
Action | Customer Notification letters dated 10/6/14 were sent to all customers who purchased the Tapered Screw Vent Implant and the Spline Twist Implant because the incorrect diameter size was printed on the inner vial. The letters informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete the attached Business Reply Form and fax it to (574) 372-4265 or email to corporatequality.postmarket@zimmer.com. Customers with questions are instructed to contact Zimmer Dental Customer Service at (800) 854-7019 from 7am-5pm, Monday-Friday. |
Quantity in Commerce | 1,044 units |
Distribution | Worldwide Distribution-US (nationwide) and the countries of Poland, Canada, Belgium, Italy, France, Israel, Morocco, Spain, Costa Rica, and Japan. |
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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