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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92732

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

Open FDA event record

Event summary

Timeline bucket
June 19, 2023
Product types
Device
Classifications
Class II
Statuses
Completed
Recalling firm wording
Materialise N.V.

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

ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide surgical instruments in mandibular and maxillofacial surgical procedures. Identification number: SD900.101

Z-2287-2023
Recall number
Z-2287-2023
Initiated
June 19, 2023
Classification
Class II
Status
Completed
Recalling firm
Materialise N.V.
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request

Code information

UDI: 05420060351013 Lot Case Number: MU23-JOQ-LID

Distribution pattern

US Nationwide distribution in the state of KY.