impression coping, repositionable, short, screw-retained, PF 4.0
Class I - DangerousWhat Should You Do?
- Check if you have this product: Article No. 3.03.079; UDI/DI: 07640156475463; Lot No. 30972.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Thommen Medical AG
- Reason for Recall:
- The depth of the internal canal was not manufactured according to specifications. Thus, the impression coping cannot be firmly connected to the implant.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
impression coping, repositionable, short, screw-retained, PF 4.0
Product Codes/Lot Numbers:
Article No. 3.03.079; UDI/DI: 07640156475463; Lot No. 30972.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1322-2024
Related Recalls
Class I - Dangerous
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).