Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67039

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

Open FDA event record

Event summary

Timeline bucket
November 26, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Materialise 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

REF 42-411571 QTY 1 CATALOG CAUTION. SEE INSTRUCTIONS FOR USE SIGNATURE M PKA GDE/MDL SET SML-MP DD.....R-FEB55RKA-T JA-A01 05551 PKA POST CUT SML-PKA MICROPLASTY CUSTOM-MADE DEVICE non-sterile The Signature Personalized Patient Care System includes the patient-specific Signature Guides which are patient specific instruments (guides are considered custom-made per EU definition) intended for use during the surgical procedure for total and partial knee arthroplasty.

Z-0628-2014
Recall number
Z-0628-2014
Initiated
November 26, 2013
Classification
Class II
Status
Terminated
Recalling firm
Materialise USA LLC
Quantity
1

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Shipped femur guide contained a non-conformance which could possibly impact fit of the drill insert.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Shipped femur guide contained a non-conformance which could possibly impact fit of the drill insert.

Code information

Lot 094929

Distribution pattern

US Distribution: MO only.

Field note

Send feedback

We'll only use this to respond to your feedback.