Adapter for handpiece, guided, reusable, for guide sleeve recallZ-1390-2019 · Thommen Medical AG · initiated Apr 3, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Thommen Medical AG or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Dental adaptor does not conform to specifications. The dental coupling of the adapter can become deformed when being inserted into the implant may make it difficult to remove the adapter from its counterpart (e.g. the handpiece).
FDA root cause category: Under Investigation by firm
What the company is doing
Thommen Medical AG notified the account on 3/27/19 via email asked distributors to put any adapters in their stock in quarantine. Furthermore recall all adapters shipped to their customers. All recovered adapters to be sent back to Thommen Medical AG, who will supply them with new adapters which conform to the specifications.
Recall details
- Recall number
- Z-1390-2019
- Status
- Terminated
- Initiated by the company
- Apr 3, 2019
- Recalling firm
- Thommen Medical AG
- Quantity
- 15 US
- Product code
- NDP
- Distribution
- US Nationwide distribution in the state of OH.
Product description
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 screwed in manually or mechanically.
Code information (models, lots, serial numbers)
Lot number:17415 UDI: 07640182640705
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Adapter for handpiece 3.04.090Thommen Medical AG · Accessories, Implant, Dental, Endosseous1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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