FDA recall Z-2580-2023

Product

Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relining Material KI Item No.: 0921940HS Henry Schein Item No.: 570-0718

Reason for recall

The Hard Line Chairside Reline Kit (570-0718) (0921940HS) was labeled as Soft Line Chairside Reline Kit (570-0717) (0921250HS) on the outer box. The contents of the Kit and the IFU enclosed with the kit were correctly labeled as Hard Line materials

Distribution

US Nationwide distribution in the states of IL, PA, FL NV, TX.

Key facts

Status

Ongoing

Initiation date

2023-04-10

Report date

2023-09-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Gibbstown, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2580-2023