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Terminated

Synthes 3.2 mm Guide Wire 400mm. Used for guiding the TFN Helical Blade and TFN Lag Screw into the femoral.

FDA Recall Z-0986-2014 · Posted 2014-02-16

Recalling FirmSynthes, Inc.
Recall StatusTerminated
Product CodeLXH
Date Initiated2014-01-27
Date Terminated2015-12-18
Product Quantity1,132,096

Reason for Recall

Synthes 3.2 mm Guide Wire 400mm included an incorrect raw material listed on the label.

Firm Action

A recall notification letter, dated January 27, 2013, was sent to End Users and sales consultants.

Root Cause

Labeling Change Control

Distribution Pattern

Worldwide Distribution-USA (nationwide) and the countries of Canada and Switzerland.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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