Dental Implant Impression Coping Recalled for Manufacturing Defect
Thommen Medical AG is recalling impression coping units because the internal canal depth was not manufactured according to specifications, preventing firm connection to the dental implant. The product was distributed in Ohio and Kentucky.
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 a Class II recall of a dental implant component with a confirmed manufacturing defect that prevents proper function. Although no injuries have been reported, the defect creates a risk of implant connection failure.
Plain-English summary
Thommen Medical AG is recalling impression coping products (Lot No. 30972) because the internal canal depth was not manufactured according to specifications. This prevents the impression coping from being firmly connected to the dental implant.
The affected product was distributed in Ohio and Kentucky. Healthcare providers and patients who have received this product should be aware of this recall.
The recalled product
- Product
- impression coping, repositionable, short, screw-retained, PF 4.0
- Manufacturer
- Thommen Medical AG
- Category
- Medical Device — Dental Implants
- Affected units
- 20
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 (3)
- Article No. 3.03.079
- UDI/DI: 07640156475463
- Lot No. 30972.
Distribution
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