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Recall Observatory FDA recall evidence

Device product

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

Z-0630-2024

November 20, 2023

Class II

Product summary

Firm
Keystone Industries
Event
Event 93522
Status
Ongoing
Classification
Class II
Quantity
336 units
Official record key
device-enforcement:Z-0630-2024

Official wording

Reason: 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).

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

Distribution pattern: Worldwide distribution - US Nationwide and the country of China.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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).