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.
What this means for you
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
Related recalls
Same manufacturer · Thommen Medical AG
See all →- ModerateThommen Medical Recalls Dental Adapters for Handpiece Due to Deformation Risk
FDA (Devices) · 2019-05-29
Same hazard · manufacturing defect
See all →- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-09-09
- HighSun Pharmaceutical Recalls Carbamazepine Tablets Due to Manufacturing Deviations
FDA (Drugs) · 2026-08-26
- HighKnee Prosthesis Trial Recall for Manufacturing Defect
FDA (Devices) · 2026-08-12
- HighUSTAR II Knee System Hinge Box Trial Recall
FDA (Devices) · 2026-08-12
- HighU2 Total Knee System Femoral Valgus Adaptor Recall
FDA (Devices) · 2026-08-12