FDA recall Z-0836-2020

Product

Paltop Dynamic Dental Implant Dia 3.25mm L 13.0 mm, Catalog Number 21-70020

Reason for recall

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.

Distribution

The products were distributed to the following US states: CA, DC, FL, GA, MA, MD, NJ, NY, SC, TX, and VA.

Key facts

Status

Terminated

Initiation date

2019-11-18

Report date

2020-01-29

Termination date

2022-12-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Caesarea, Israel

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0836-2020