Exact FDA event identifier

Event 98265

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: January 06, 2026
Product types: Device
Classifications: Class III
Statuses: Ongoing
Recalling firm wording: Straumann USA LLC

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM

Z-1337-2026

Recall number: Z-1337-2026
Initiated: January 06, 2026
Classification: Class III
Status: Ongoing
Recalling firm: Straumann USA LLC
Quantity: 561 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown.

Code information

Article Number: 065.4810; UDI-DI: 07630031741110; Lot numbers: VWPX4, VWPX6;

Distribution pattern

US Nationwide distribution.