Synthes 3.2 mm Guide Wire 400mm. Used for guiding the TFN Helical Blade and TFN Lag Screw into the femoral.
FDA device recall Z-0986-2014 · posted 2014-02-16 · Terminated
Recall details
- Recalling firm
- Synthes, Inc.
- Reason for recall
- Synthes 3.2 mm Guide Wire 400mm included an incorrect raw material listed on the label.
- Action taken
- A recall notification letter, dated January 27, 2013, was sent to End Users and sales consultants.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 1,132,096
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Canada and Switzerland.
- Date initiated
- 2014-01-27
- Date posted
- 2014-02-16
- Date terminated
- 2015-12-18
- Location
- West Chester, PA
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