impression coping, repositionable, short, screw-retained, PF 4.0

FDA device recall Z-1322-2024 · posted 2024-03-20 · Open, Classified

Recall details

Recalling firm

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.

Action taken

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.

Root cause

Process change control

Status

Open, Classified

Product code

NDP

Quantity affected

20 units

Distribution

US Nationwide distribution in the states of OH and KY.

Date initiated

2024-01-24

Date posted

2024-03-20

Location

Bettlach, Switzerland