FDA recall Z-0630-2024

Product

KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, repositioners, and retainers Item No.: 4220011

Reason for recall

Keyprint Keysplint Hard Clear 1 kg resin bottles were inadvertently packaged with the wrong Instructions for Use. Keysplint Hard Clear were placed inside a zip lock bag along with KeySplint Soft Instructions for Use (IFU).

Distribution

Worldwide distribution - US Nationwide and the country of China.

Key facts

Status

Ongoing

Initiation date

2023-11-20

Report date

2024-01-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Gibbstown, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0630-2024