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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81926

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
January 10, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Ottobock Orthopedic Industrie

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

3 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 3

21Y14 PushValve Product Usage: The PushValves/ MagValves is intended exclusively for the prosthetic fitting of lower limb amputees. The valve is a threadless one-way valve. It is used to evacuate air from the prosthetic socket.

Z-0826-2019
Recall number
Z-0826-2019
Initiated
January 10, 2019
Classification
Class II
Status
Terminated
Quantity
538 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some of the installed valve-inserts have a diameter smaller than the specification.

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

Some of the installed valve-inserts have a diameter smaller than the specification.

Code information

The products with an article number listed below and delivered between May 1, 2017 and January 19, 2018

Distribution pattern

US Nationwide Distribution

device · product 2 of 3

21Y14=S PushValve upper part Product Usage: The PushValves/ MagValves is intended exclusively for the prosthetic fitting of lower limb amputees. The valve is a threadless one-way valve. It is used to evacuate air from the prosthetic socket.

Z-0827-2019
Recall number
Z-0827-2019
Initiated
January 10, 2019
Classification
Class II
Status
Terminated
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some of the installed valve-inserts have a diameter smaller than the specification.

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

Some of the installed valve-inserts have a diameter smaller than the specification.

Code information

The products with an article number listed below and delivered between May 1, 2017 and January 19, 2018

Distribution pattern

US Nationwide Distribution

device · product 3 of 3

21Y15 MagValve Product Usage: The PushValves/ MagValves is intended exclusively for the prosthetic fitting of lower limb amputees. The valve is a threadless one-way valve. It is used to evacuate air from the prosthetic socket.

Z-0828-2019
Recall number
Z-0828-2019
Initiated
January 10, 2019
Classification
Class II
Status
Terminated
Quantity
110 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some of the installed valve-inserts have a diameter smaller than the specification.

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

Some of the installed valve-inserts have a diameter smaller than the specification.

Code information

The products with an article number listed below and delivered between May 1, 2017 and January 19, 2018

Distribution pattern

US Nationwide Distribution