Keystone Industries: Medical Device Recall in 2024 - (Recall #: Z-0630-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 20, 2023

Date Posted: January 10, 2024

Recall Number: Z-0630-2024

Event ID: 93522

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).

Status: Ongoing

Product Quantity: 336 units

Code Information:

UDI: UDI +H66842200111/$$3251116NB3628L Lot No. NB3628

Distribution Pattern:

Worldwide distribution - US Nationwide and the country of China.

Voluntary or Mandated:

Voluntary: Firm initiated