PALLAS M/MAXIMIS Torque Handle. 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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Catalog No. 0902-1033. Known Lot No. WNV120810, WNV111109.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Valorem Surgical LLC
- Reason for Recall:
- Devices are not consistent with Quality System Requirements.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
PALLAS M/MAXIMIS Torque Handle. 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.
Product Codes/Lot Numbers:
Catalog No. 0902-1033. Known Lot No. WNV120810, WNV111109.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-3002-2017
Related Recalls
Devices are not consistent with Quality System Requirements.
Devices are not consistent with Quality System Requirements.
Devices are not consistent with Quality System Requirements.