FDAFDA · Food and drugs·Recall number Z-0225-2015
The MectaLIF Oblique Handle, model number 03.22.10.0262, is used to insert the MectaLIF oblique spinal cage implants.
Published November 26, 2014 · Recall initiated: October 21, 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
The MectaLIF Oblique Handle has the laser marking "MEDIAL" on the incorrect side and could result in incorrect insertion of the device during surgery.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Medacta Usa
- Distributor
- Worldwide Distribution - US including CA, CO, ID and Internationally to Australia and Germany.
- Lot
- Model Number: 03.22.10.0262; Lot Number: 1314256
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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