Coltene Whaledent Recalls ParaPost Plus Titanium Dental Posts
Coltene Whaledent Inc is recalling ParaPost Plus 25 Titanium Alloy dental posts because they contain stainless steel posts that are a size 4.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity recall.
Plain-English summary
Coltene Whaledent Inc is recalling ParaPost Plus 25 Titanium Alloy Spiral Vented and Serrated Posts, Catalog Number P2845B. These dental posts are implanted into teeth for dental restoration purposes. The recall is being conducted because the ParaPost Plus Titanium Posts contain stainless steel posts that are a size 4.
The affected product consists of 30 packets, identified by Batch I33012. The products were distributed in the United States to the states of California, Illinois, Nevada, New York, Pennsylvania, and Washington, as well as to Canada.
Consumers who have purchased these dental posts should contact Coltene Whaledent Inc for further instructions on how to proceed with the recall.
The recalled product
- Product
- ParaPost Plus 25 Titanium Alloy Spiral Vented and Serrated Posts Catalog Number: P2845B Dental Posts are implanted into teeth for dental restoration purposes. The normal procedure requires a hole to be drilled into the tissue of a tooth with an intraoral drill prior to…
- Manufacturer
- Coltene Whaledent Inc
- Category
- Medical Device — Dental
- Hazard
- Affected units
- 30
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)
- Batch I33012
Distribution
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