Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy

Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

ยฉ 2026 Go Backs. All rights reserved.

Medium RiskFDA Device
Medical Devices/Implants & Prosthetics

Thommen Medical AG: Impression Coping Recalled Due to Manufacturing Defect

Agency Publication Date: March 20, 2024
Share:
Sign in to monitor this recall

Summary

Thommen Medical AG is recalling 20 units of its repositionable, short, screw-retained impression coping (PF 4.0) because the depth of the internal canal was not manufactured according to specifications. This defect prevents the impression coping from being firmly connected to the dental implant during procedures. Consumers and dental professionals should be aware that this manufacturing error can lead to inaccurate dental impressions and potential procedural delays.

Risk

The internal canal's incorrect depth prevents a secure connection between the coping and the implant, which could lead to instability or errors during dental impression taking. No injuries have been reported to date, but the defect compromises the device's intended surgical and restorative function.

What You Should Do

  1. Check your dental inventory for the 'impression coping, repositionable, short, screw-retained, PF 4.0' with Article Number 3.03.079 and Lot Number 30972.
  2. Verify the product using the UDI/DI barcode number 07640156475463 found on the packaging.
  3. Immediately stop using any affected coping devices that match the identified lot number.
  4. Contact your healthcare provider or Thommen Medical AG directly at their headquarters in Bettlach, Switzerland, or through their official website for instructions on returning the defective units.
  5. Call the FDA's medical device hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional assistance or to report any complications.

Your Remedy Options

๐Ÿ“‹Other Action

Healthcare provider or manufacturer consultation

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: impression coping, repositionable, short, screw-retained, PF 4.0
Model / REF:
Article No. 3.03.079
UPC Codes:
07640156475463
Lot Numbers:
30972

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94040
Status: Active
Manufacturer: Thommen Medical AG
Sold By: Specialty dental distributors
Manufactured In: Switzerland
Units Affected: 20 units
Distributed To: Ohio, Kentucky
Agency Last Updated: March 25, 2024

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.