FDAFDA · Food and drugs·Recall number Z-0986-2014
Synthes 3.2 mm Guide Wire 400mm. Used for guiding the TFN Helical Blade and TFN Lag Screw into the femoral.
Published February 26, 2014 · Recall initiated: January 27, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Synthes 3.2 mm Guide Wire 400mm included an incorrect raw material listed on the label.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Synthes, Inc.
- Distributor
- Worldwide Distribution-USA (nationwide) and the countries of Canada and Switzerland.
- Lot
- part No. 357.399 with all lot numbers 4440270 through 49991803, 5000218 through 5894644, 6000409 through 6999404, 7000143 through 7531836, UK09636, UK10233, UK10510, UL11099, and UL11333.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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