Synthes 3.2 mm Guide Wire 400mm. Used for guiding the TFN Helical Blade and TFN Lag Screw into the femoral.
Reported: February 26, 2014 Initiated: January 27, 2014 #Z-0986-2014
Product Description
Synthes 3.2 mm Guide Wire 400mm. Used for guiding the TFN Helical Blade and TFN Lag Screw into the femoral.
Reason for Recall
Synthes 3.2 mm Guide Wire 400mm included an incorrect raw material listed on the label.
Details
- Recalling Firm
- Synthes, Inc.
- Units Affected
- 1,132,096
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Canada and Switzerland.
- Location
- West Chester, PA
Frequently Asked Questions
What product was recalled? ▼
Synthes 3.2 mm Guide Wire 400mm. Used for guiding the TFN Helical Blade and TFN Lag Screw into the femoral.. Recalled by Synthes, Inc.. Units affected: 1,132,096.
Why was this product recalled? ▼
Synthes 3.2 mm Guide Wire 400mm included an incorrect raw material listed on the label.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 26, 2014. Severity: Moderate. Recall number: Z-0986-2014.
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