impression coping, repositionable, short, screw-retained… recallZ-1322-2024 · Thommen Medical AG · initiated Jan 24, 2024
Open, Classified
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
The depth of the internal canal was not manufactured according to specifications. Thus, the impression coping cannot be firmly connected to the implant.
FDA root cause category: Process change control
What the company is doing
Urgent Field Safety Notice letters dated February 05, 2024 were sent to customers. Customers were instructed to: Ensure that the contents of this Field Safety Notice are read and understood within your organization. Locate and quarantine affected devices immediately. If you have further distributed the product to other organizations, please inform them at once of this FSCA and provide them with a copy of this letter. Return all affected products of the listed lot number to Thommen Medical AG. The products will be replaced by Thommen MedicalAG. Please acknowledge and confirm receipt of this urgent safety information using the enclosed reply form and return it to us together with the retrieved devices. For further questions please contact: Bibiana Gamper Phone: +41 61 965 90 55 E-Mail [email protected].
Recall details
- Recall number
- Z-1322-2024
- Status
- Open, Classified
- Initiated by the company
- Jan 24, 2024
- Posted by the FDA
- Mar 20, 2024
- Recalling firm
- Thommen Medical AG
- Quantity
- 20 units
- Product code
- NDP
- Distribution
- US Nationwide distribution in the states of OH and KY.
Product description
impression coping, repositionable, short, screw-retained, PF 4.0
Code information (models, lots, serial numbers)
Article No. 3.03.079; UDI/DI: 07640156475463; Lot No. 30972.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Impression coping 3.03.079Thommen 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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