Z-1818-2017 Class II Terminated
FDA device recall Z-1818-2017 was initiated by Keystone Dental Inc on March 9, 2017 and is designated Class II. Reason for recall: Straight PrimaConnex Implants contained Tapered PrimaConnex Implants The recall status is terminated (terminated July 5, 2017). Affected quantity: 59 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 19, 2017
- Initiation Date
- March 9, 2017
- Termination Date
- July 5, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 59 units
Product Description
Keystone Dental Inc. PrimaConnex Straight Implant TC, WD Internal Connection 5.0 x 11.5mm. Catalog Number(s): 15636K
Reason for Recall
Straight PrimaConnex Implants contained Tapered PrimaConnex Implants
Distribution Pattern
CA, IL, IN, FL, MA, MN, NJ, NV, PA,
Code Information
Lot Number: 30214