FDA Medical Device Recalls (openFDA)
Thommen Medical AG: impression coping, repositionable, short, screw-retained, PF 4.0
- Recall number
- Z-1322-2024
- Recalling firm
- Thommen Medical AG
- Product
- impression coping, repositionable, short, screw-retained, PF 4.0
- Status
- Open, Classified
- Initiated
- 2024-01-24
- Posted
- 2024-03-20
- Terminated
- not on file
- Reason
- The depth of the internal canal was not manufactured according to specifications. Thus, the impression coping cannot be firmly connected to the implant.
- Root cause
- Process change control
- Action
- 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 reoulatory@thommenmedical.com.
- Quantity
- 20 units
- Distribution
- US Nationwide distribution in the states of OH and KY.
- Lot, serial or model codes
- Article No. 3.03.079; UDI/DI: 07640156475463; Lot No. 30972.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NDP
- Firm FEI
- 3003184527
- Firm city
- Bettlach
- Firm state
- not on file
- Firm country
- Switzerland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28