Affinity Dental Impression Material Recalled for Wrong Material
Clinician's Choice Dental Products is recalling Affinity Hydroactive Impression Material Heavy Body Regular Set because Template Ultra Quick matrix Material was packaged instead of the indicated Heavy Body viscosity. The recall affects 46 units distributed in South Carolina.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a confirmed product substitution error—Template Ultra Quick material was packaged instead of the ordered Heavy Body material. No illnesses or injuries have been reported. This qualifies as a risk-of-harm product without reported injury under the rubric criteria for High-severity recalls.
Plain-English summary
Clinician's Choice Dental Products Inc. is recalling Affinity Hydroactive Impression Material Heavy Body Regular Set 12PK (Product ID: 013912, Lot No. 611612) due to a packaging error. The company distributed 46 units of this material in South Carolina.
The problem: Template Ultra Quick matrix Material was packaged inside the product boxes instead of the Heavy Body viscosity material as indicated on the outer packaging. Dental professionals who open these packages expecting Heavy Body material will instead receive the Template Ultra Quick product. This viscosity mismatch could affect the quality and performance of dental impressions created with the material.
If you received this product, contact Clinician's Choice Dental Products Inc. to arrange for return and replacement with the correct Heavy Body material. Dental practices should verify the contents and viscosity specifications of any impression materials from this lot.
The recalled product
- Product
- Affinity Hydroactive Impression Material Heavy Body Regular Set 12PK- A vinyl poly siloxane material used to create, via impression, a reproduction of tooth and gum structure. Product ID: 013912
- Manufacturer
- Clinician's Choice Dental Products Inc.
- Category
- Medical Device — Dental Material
- Affected units
- 46
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 No.: 611612 (UDI): 07540172000178
Distribution
Distributed in 1 state:
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