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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 70477

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

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Event summary

Timeline bucket
February 02, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Microport Orthopedics INC.

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

EVOLUTION MP TIBIAL BASE, REF ETPKN8SR, SIZE 8 RIGHT, TYPE PRIMARY, FIT CEMENTED, STYLE KEELED, STERILE R, Rx ONLY, MicroPort Orthopedics, Inc. Knee prosthesis component.

Z-1249-2015
Recall number
Z-1249-2015
Initiated
February 02, 2015
Classification
Class II
Status
Terminated
Quantity
17 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some units of the EVOLUTION Tibial Base was affected by a casting tool issue which caused varying retaining wall thickness and keel offset in the finished product.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some units of the EVOLUTION Tibial Base was affected by a casting tool issue which caused varying retaining wall thickness and keel offset in the finished product.

Code information

Lot Numbers: 1560140, 15601401568897, 15601401570896

Distribution pattern

Worldwide Distribution - USA including AL, AZ, ID, KS, KS, MO, TX, IA, WV and Internationally to Canada and The Netherlands.