FDAFDA · Food and drugs·Recall number Z-0960-2017
Tiger Screw Sterilization Tray Base Assembly Model 210-00-001 Revision N, O The product is a component of a system indicated for the fixation of fractures, non-unions, arthrodeses, and osteotomies of bones appropriate for the size of the device.
Published January 18, 2017 · Recall initiated: December 8, 2016
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
Four lots of Tiger Screw Sterilization Tray Base Assemblies were released to the field with a printing error where k-wire description markings indicate diameters of 0.45 and 0.35 instead of 0.045" and 0.035", respectively.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Trilliant Surgical Ltd.
- Distributor
- Nationwide Distribution
- Lot
- Lot: TSL003191, TSL003637, TSL004101, TSL004395
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.