Z-0299-2017 Class II Terminated
FDA device recall Z-0299-2017 was initiated by Keystone Dental Inc on September 15, 2016 and is designated Class II. Reason for recall: Small diameter (SD) cover screw was packaged with the regular diameter implant and do not match the implant diameter (RD) The recall status is terminated (terminated January 3, 2017). Affected quantity: 55 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 2, 2016
- Initiation Date
- September 15, 2016
- Termination Date
- January 3, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 55 units
Product Description
Keystone Dental PrimaConnex¿ Straight Implant TC, RD Internal Connection 4.0 x 11.5mm. Product code:15613K Implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations includ-ing; cement retained, screw retained, or overdenture restorations and terminal or inter-mediate abutment support for fixed bridgework
Reason for Recall
Small diameter (SD) cover screw was packaged with the regular diameter implant and do not match the implant diameter (RD)
Distribution Pattern
Worldwide distribution - US (Nationwide Distribution to CA, CO, IL, MA, MN, ND, NY, NV, PA, and VA.) and Italy
Code Information
Lot # 27714