FDA recall Z-0376-2019

Product

ParaPost Plus 25 Titanium Alloy Spiral Vented and Serrated Posts Catalog Number: P2845B Dental Posts are implanted into teeth for dental restoration purposes. The normal procedure requires a hole to be drilled into the tissue of a tooth with an intraoral drill prior to installation.

Reason for recall

ParaPost Plus Titanium Posts contain stainless steel post that are a size 4

Distribution

US Distribution to states of: CA, IL, NV, NY, PA, and WA' and to country of: Canada.

Key facts

Status

Terminated

Initiation date

2018-08-21

Report date

2018-11-14

Termination date

2020-04-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cuyahoga Falls, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0376-2019