FDA Device recall Z-1322-2024
impression coping, repositionable, short, screw-retained, PF 4.0
- FDA Device
- Class II
- ongoing
- Published 2024-03-27
On 2024-03-27 the FDA classified a Class II recall of impression coping, repositionable, short, screw-retained, PF 4.0 by Thommen Medical Ag, citing the depth of the internal canal was not manufactured according to specifications. Thus, the impression coping cannot be firmly connected to the implant.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1322-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-01-24 |
| Published | 2024-03-27 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Thommen Medical Ag |
| Distribution | US |
Product
impression coping, repositionable, short, screw-retained, PF 4.0
Reason
The depth of the internal canal was not manufactured according to specifications. Thus, the impression coping cannot be firmly connected to the implant.
Identifiers
| code_info | Article No. 3.03.079; UDI/DI: 07640156475463; Lot No. 30972. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1322-2024%22
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