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.
FDA Recall Z-0153-2015 · Posted 2014-10-30
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Recalling FirmZimmer Dental Inc
Recall StatusTerminated
Product CodeDZE
Date Initiated2014-10-01
Date Terminated2015-04-28
Product Quantity1,044 units
Reason for Recall
Zimmer Dental is recalling Tapered Screw-Vent Implants because the incorrect diameter size was printed on the inner vial.
Firm 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 [email protected]. Customers with questions are instructed to contact Zimmer Dental Customer Service at (800) 854-7019 from 7am-5pm, Monday-Friday.
Root Cause
Labeling Change Control
Distribution Pattern
Worldwide Distribution-US (nationwide) and the countries of Poland, Canada, Belgium, Italy, France, Israel, Morocco, Spain, Costa Rica, and Japan.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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