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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82796

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

Open FDA event record

Event summary

Timeline bucket
May 09, 2019
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
I.T.S. GmbH

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

Rim Plate, 10-Hole, Left, PRS RX System. Titanium, implantable - Product Usage: The implant temporarily stabilizes bone segments until bony consolidation has taken place. After this, the implant has no more use and can be removed.

Z-1718-2019
Recall number
Z-1718-2019
Initiated
May 09, 2019
Classification
Class II
Status
Ongoing
Recalling firm
I.T.S. GmbH
Quantity
65 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The titanium implant has the wrong article number laser marked on it.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The titanium implant has the wrong article number laser marked on it.

Code information

Model Number: 21206-10; Lot Code: 26/F42778

Distribution pattern

Worldwide distribution - US nationwide distribution in the states of Florida and Puerto Rico, and countries of Austria, Netherlands, Slovenia, South Africa, Switzerland.