Ultradent Recalls InterGuard Dental Refills Due to Manufacturing Defect
Ultradent is recalling InterGuard 5.5mm Econo Refills because the floss tether hole was not completely punched through.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is due to a manufacturing defect where a hole was not completely punched through, which is a cosmetic or functional defect without reported injuries or significant health risks.
Plain-English summary
Ultradent Products, Inc. is recalling InterGuard 5.5mm Econo Refills, part # 4012, in sizes 4.0mm and 5.5mm. The recall affects 157 units from lot numbers BC2GN and BC4L7.
The product is being recalled because it was received from the supplier with the floss tether hole not completely punched through. InterGuard is a preventive aid for operative dentistry used to protect adjacent teeth from iatrogenic preparation damage.
The affected products were distributed worldwide, including in the United States, Austria, Canada, Colombia, Denmark, France, Germany, Great Britain, Iceland, and Portugal. Consumers and healthcare providers should stop using the affected lots and contact Ultradent for instructions on return or replacement.
The recalled product
- Product
- InterGuard 5.5mm Econo Refill, sizes, 4.0mm for short anatomical crowns and 5.5mm, part # 4012 Product Usage: InterGuard is a preventive aid for operative dentistry. It is used to protect adjacent teeth from iatrogenic preparation damage. This includes cavity and tunnel…
- Manufacturer
- Ultradent Products, Inc.
- Category
- Medical Device — Dental Supplies
- Hazard
- Affected units
- 157
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- lot#s BC2GN and BC4L7
Distribution
Distributed nationwide across the United States.
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