Thommen Medical Recalls Dental Adapters for Handpiece Due to Deformation Risk
Thommen Medical AG is recalling 15 units of dental adapters for handpieces because the coupling may deform, making removal difficult.
What this means for you
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. The hazard involves a mechanical defect (deformation) that may make the device difficult to remove, but the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
Thommen Medical AG is recalling 15 units of the Adapter for handpiece, guided, reusable, for guide sleeve 0 4.8 mm (Article number: 3.04.090). The product is used to transfer implants from packaging to patients via a plug-in connection.
The recall was initiated because the dental coupling of the adapter does not conform to specifications. Specifically, the coupling can become deformed when inserted into the implant, which may make it difficult to remove the adapter from its counterpart, such as the handpiece.
The affected units were distributed nationwide in the state of Ohio. The specific lot number is 17415 and the UDI is 07640182640705. Consumers and healthcare providers should stop using the affected adapters and contact the recalling firm for further instructions.
The recalled product
- Product
- Adapter for handpiece, guided, reusable, for guide sleeve 0 4.8 mm Article number: 3.04.090 - Product Usage: The adapter for handpiece, guided reusable, for guide sleeve ¿ 4.8 mm is used to transfer the implant from the packaging to the patient via a plug-in connection and scre
- Manufacturer
- Thommen Medical AG
- Affected units
- 15
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 number:17415 UDI: 07640182640705
Distribution
Related recalls
Same manufacturer · Thommen Medical AG
See all →- HighDental Implant Impression Coping Recalled for Manufacturing Defect
FDA (Devices) · 2024-03-27
Same hazard · mechanical defect
See all →- HighMobile Digital Radiographic System Arm Drop Risk During Patient Exams
FDA (Devices) · 2026-07-22
- ModerateSurgical driver systems recalled over out of the box driver wobble
FDA (Devices) · 2025-09-03
- HighBeckman Coulter DxI 9000 Analyzer wash wheel mixer defect may prevent operation
FDA (Devices) · 2025-03-19
- SevereBaxter Spectrum IQ Infusion System may have missing motor mounting screws
FDA (Devices) · 2025-03-12
- HighVNS Therapy Generator May Stop Delivering Stimulation Due to Mechanical Defect
FDA (Devices) · 2025-02-12