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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 75951

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

Open FDA event record

Event summary

Timeline bucket
December 13, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
On-X Life Technologies, 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

Chord-X Chordal Sizer is designed to assist in determining the proper length of chordal replacement prostheses to repair the mitral valve and help the surgeon select a preconfigured prosthesis, or configure the correct size using straight suture material, during mitral valve repair.

Z-1057-2017
Recall number
Z-1057-2017
Initiated
December 13, 2016
Classification
Class II
Status
Terminated
Quantity
45 units

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
particulate
Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Assembly error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Four issues were uncovered by the recalling firm's CAPA: 1) Burrs were found to be present on Left Housing, Right Housing and Barrel components, 2) Loose plastic particulate was found within sealed primary packages, 3) Loose hair was discovered within four sealed primary packages and 4) Assembly error, wherein Left and Right Housing components were acceptably press-fit together, was discovered within one sealed primary package. One of the Left Housing press-fit pins was not pressed into the associated hole of the Right Housing, resulting in a small gap in the housing assembly.

Code information

72-00-47420

Distribution pattern

CA, WA, NE, DE, OH, ME, TX