Chord-X Chordal Sizer is designed to assist in determining the proper length of chordal replacement prostheses to repair

FDA device recall Z-1057-2017 · posted 2017-01-20 · Terminated

Recall details

Recalling firm

On-X Life Technologies, Inc.

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.

Action taken

A letter was sent to the implanting surgerons notifyijng them of the recall and attemmpting retrieval.

Root cause

Component design/selection

Status

Terminated

Product code

PAW

Quantity affected

45 units

Distribution

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

Date initiated

2016-12-13

Date posted

2017-01-20

Date terminated

2017-04-13

Location

Austin, TX

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