CLASS III ONGOING Device recall · Reported 18 Feb 2026 · FDA Enforcement Report
WB Impression Post Closed Tray incl recalled by Straumann USA
Straumann USA is recalling WB Impression Post Closed Tray incl, distributed nationwide in the US. The recall was initiated on 6 Jan 2026 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1337-2026
- FDA event ID
- 98265
- Recalling firm
- Straumann USA, Andover, MA
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 6 Jan 2026
- FDA classified
- 9 Feb 2026
- Reported
- 18 Feb 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 6 Jan 2026 | Recall initiated by company | |
| 9 Feb 2026 | Classified by FDA | +34 days |
| 18 Feb 2026 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown.
Which lots are affected?
Article Number: 065.4810; UDI-DI: 07630031741110; Lot numbers: VWPX4, VWPX6;
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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