FDA Device recall Z-1337-2026
WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM
- FDA Device
- Class III
- ongoing
- Published 2026-02-18
On 2026-02-18 the FDA classified a Class III recall of WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM by Straumann Usa, citing the mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1337-2026 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2026-01-06 |
| Published | 2026-02-18 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Straumann Usa |
| Distribution | US |
Product
WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM
Reason
The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown.
Identifiers
| code_info | Article Number: 065.4810; UDI-DI: 07630031741110; Lot numbers: VWPX4, VWPX6; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1337-2026%22
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