FDAFDA · Food and drugs·Recall number Z-2947-2017
PALLAS M/MAXIMIS 35mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
Published August 16, 2017 · Recall initiated: June 21, 2017
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
Devices are not consistent with Quality System Requirements.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Valorem Surgical LLC
- Distributor
- Nationwide Distribution - US including CA and VA.
- Lot
- Catalog No. S060-035; Known Lot No. NHS100106.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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