FDAFDA · Food and drugs·Recall number Z-2465-2015
Salto Talaris Tibial Guide, Part # MJU333 ,Tray/Kit Code YKAL11, Non sterile. Orthopedic Manual Surgical Instrument
Published September 2, 2015 · Recall initiated: August 6, 2015
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
Tornier has initiated a voluntary recall for the Salto Talaris Tibial Guide (part number MJU333) due to a complaint that occurred during physician training, that the guide cannot be assembled to the Salto Talaris Talar Pin Setting guide. This issue will cause the impossibility the time of putting the Talar pin in the guide.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Tornier, Inc
- Distributor
- Distributed to CA, ME, NC, PA, and TX.
- Lot
- Lot #14F005
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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