Recall Z-0153-2015— Zimmer Dental Inc
Class II · Terminated
Class II FDA medical device recall by Zimmer Dental Inc, initiated 2014-10-01, terminated 2015-04-28. It names one FDA 510(k) clearance: K093164. 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.. Reason: Zimmer Dental is recalling Tapered Screw-Vent Implants because the incorrect diameter size was printed on the inner vial..
- Recalling firm
- Zimmer Dental Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-10-01
- Terminated
- 2015-04-28
- Firm location
- Carlsbad, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
Zimmer Dental is recalling Tapered Screw-Vent Implants because the incorrect diameter size was printed on the inner vial.
Data sourced from openFDA. This site is unofficial and independent of the FDA.