Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86113

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

Open FDA event record

Event summary

Timeline bucket
July 17, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
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

Match Point System The Match Point System is intended to by uses as a surgical instrument to assist in the intraoperative positioning of glenoid components used with total and reverse shoulder arthroplasty by referencing anatomic landmarks of the shoulder that are identifiable on preoperative CT-image scans.

Z-2886-2020
Recall number
Z-2886-2020
Initiated
July 17, 2020
Classification
Class II
Status
Terminated
Recalling firm
Materialise N.V.
Quantity
128

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The procedure side indicated in the top header of the Shoulder Case Planning Report incorrectly indicated the procedure side as "Left" for surgical plans for a "right" procedure side.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Design Change

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The procedure side indicated in the top header of the Shoulder Case Planning Report incorrectly indicated the procedure side as "Left" for surgical plans for a "right" procedure side.

Code information

ID #s: 804-03-057, 804-25-148, 804-03-058, 804,07,022 UDI #s: E314804030570, E314804251480, E314804070220

Distribution pattern

Nationwide distribution to: US including PR and International to UK and Australia.