Z-1061-2019 Class II Terminated
FDA device recall Z-1061-2019 was initiated by Keystone Dental Inc on February 22, 2019 and is designated Class II. Reason for recall: Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature The recall status is terminated (terminated June 19, 2020). Affected quantity: 13 kits hex Driver.
Recall Details
- Product Type
- Devices
- Report Date
- April 3, 2019
- Initiation Date
- February 22, 2019
- Termination Date
- June 19, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13 kits hex Driver
Product Description
Paltop Premium Surgical Kit-containing the 1.25mm Hex Driver For surgical and restorative applications prosthetic devices, such as artificial teeth Part Number: 60-70112
Reason for Recall
Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature
Distribution Pattern
FL, MA, SC, VA
Code Information
Lot Numbers: WO-010252, WO-010136