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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71950

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

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Event summary

Timeline bucket
August 12, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Otto Bock Healthcare Product

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

Otto Bock Healthcare Products GmbH Genium X3 Model Number: 3B5-2, Manufacturer Otto Bock Healthcare Products GmbH. Intended to be used solely for lower limb prosthetic fittings.

Z-2438-2015
Recall number
Z-2438-2015
Initiated
August 12, 2015
Classification
Class II
Status
Terminated
Quantity
1

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Otto Bock Healthcare Products GmbH is recalling the new Genium X3 knee joint prosthesis due to issues with the resistance-control of the hydraulics, which may fail under conditions.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

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Inspect official wording and provenance

Reason for recall

Otto Bock Healthcare Products GmbH is recalling the new Genium X3 knee joint prosthesis due to issues with the resistance-control of the hydraulics, which may fail under conditions.

Code information

Serial Number 201528049, manufactured on 01 July 2015

Distribution pattern

Distributed to the state OH.