Reported Jan 10, 2024 · Ongoing
KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as mouthguards,…
Keystone Industries
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Keystone Industries · 480 S Democrat Rd · Gibbstown, NJ · 08027-1239
Is this the product you have?
- KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, repositioners, and retainers Item No.: 4220011
- Lot codes and dates
- UDIUDI +H66842200111/$$3251116NB3628L Lot No. NB3628
- Amount recalled
- 336 units
Where it was sold
- Nationwide
Why it was recalled
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).
This product could cause temporary or reversible health problems — stop using it.
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