Device product
Paltop Dynamic Dental Implant Dia 3.25mm L 13.0 mm, Catalog Number 21-70020
Z-0836-2020
Product summary
- Event
- Event 84412
- Status
- Terminated
- Classification
- Class II
- Quantity
- 67
- Official record key
device-enforcement:Z-0836-2020
Official wording
Reason: Some of the implants were packaged with a Standard Platform Cover Screw instead of a Narrow Platform Cover Screw. The Standard Platform Cover Screw will not fit in the Narrow Platform implant.
Code information: UDI: 07290108695649; Lot Number WO-011320
Distribution pattern: The products were distributed to the following US states: CA, DC, FL, GA, MA, MD, NJ, NY, SC, TX, and VA.
Derived failure modes
-
Unknown
Some of the implants were packaged with a Standard Platform Cover Screw instead of a Narrow Platform Cover Screw. The Standard Platform Cover Screw will not fit in the Narrow Platform implant.