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

Recall Insight

This FDA Devices action (record #Z-1322-2024) was formally reported on March 27, 2024, with the manufacturer initiating the action on January 24, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Thommen Medical Ag is listed as the recalling firm, operating out of Bettlach. Federal records indicate 20 units units are affected.

The documented reason for this recall is: The depth of the internal canal was not manufactured according to specifications. Thus, the impression coping cannot be firmly connected to the implant. Distribution data in the federal record shows the product reached: US Nationwide distribution in the states of OH and KY.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC and NHTSA going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 2 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.