Z-1322-2024Class II

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

Name: Z-1322-2024 impression coping, repositionable, short, screw-retained, PF 4.0
Creator: Thommen Medical AG
Published: 2024-01-24
License: https://open.fda.gov/license/

Thommen Medical AG / initiated 2024-01-24 / Open, Classified / root cause: manufacturing process

FDA source

Thommen Medical AG began a recall of impression coping, repositionable, short, screw-retained, PF 4.0 on 2024-01-24. FDA classified it as Class II and gives the reason as "The depth of the internal canal was not manufactured according to specifications. Thus, the impression coping cannot be firmly connected to the implant". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1322-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-01-24
Posted: 2024-03-20
Recalling firm: Thommen Medical AG
Product: impression coping, repositionable, short, screw-retained, PF 4.0
Product code: NDP Accessories, Implant, Dental, Endosseous
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.
Root cause tag: manufacturing process
FDA 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 [email protected].
Quantity in commerce: 20 units
Distribution: US Nationwide distribution in the states of OH and KY.
Product codes and lots: Article No. 3.03.079; UDI/DI: 07640156475463; Lot No. 30972.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1322-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1322-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-27	2024-03-20

Product code NDP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)