FDA Enforcement
Class II
Terminated
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
Recall: Z-1061-2019
·
Reported April 3, 2019
Enforcement
- Recall Number
- Z-1061-2019
- Event ID
- 82374
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Keystone Dental Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- April 3, 2019
- Initiation Date
- February 22, 2019
- Classification Date
- March 27, 2019
- Termination Date
- June 19, 2020
- Address
- 154 Middlesex Tpke, N/A, Burlington, MA, 01803-4403, United States
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
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
Code Info
Lot Numbers: WO-010252, WO-010136
Distribution
FL, MA, SC, VA
Quantity
13 kits hex Driver