Z-0973-2013 Class II Terminated
FDA device recall Z-0973-2013 was initiated by Keystone Dental Inc on March 11, 2013 and is designated Class II. Reason for recall: Mislabeled: Cover screw that was in the package was a WD cover screw and not a SD cover screw as labeled The recall status is terminated (terminated September 26, 2013). Affected quantity: 120 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 27, 2013
- Initiation Date
- March 11, 2013
- Termination Date
- September 26, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 120 units
Product Description
PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog Number: l5613K. Implants in support for fixed bridgework.
Reason for Recall
Mislabeled: Cover screw that was in the package was a WD cover screw and not a SD cover screw as labeled
Distribution Pattern
Worldwide Distribution-USA including DC and the states of CA, FL, IN, MA, MN, NJ, NY, NH, PA, WI, and NY, and the countries of Republic of China, Germany, and France.
Code Information
Lot Number: 12857