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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92621

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

Open FDA event record

Event summary

Timeline bucket
April 26, 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

MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments (PSI)-- patient-matched device designed to fit the patients anatomy to transfer a patient-specific pre-operative plan to the OR. Ref: KNM-ZB02-00-01

Z-2213-2023
Recall number
Z-2213-2023
Initiated
April 26, 2023
Classification
Class II
Status
Completed
Recalling firm
Materialise N.V.
Quantity
2 Guides

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The wrong tibia guide was included intended for a different patient case.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The wrong tibia guide was included intended for a different patient case.

Code information

UDI-DI: (01)05420060310027 Lot Number/Case Number: ZB22UHINEF, ZB23MANOLA

Distribution pattern

International Distribution to countries of: Germany, Netherlands