BIOMET Spine, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System. Rx Only. Non-Sterile. Intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system
Class I - DangerousWhat Should You Do?
- Check if you have this product: Multiple Item and Lot numbers. The firm expects all Translation Screw Systems (containing a cobalt chrome component) used and contacted with the SpF Implantable Spine Fusion Stimulator (DC electrical current) to be at risk for this failure mode.
- 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:
- Ebi, Llc
- Reason for Recall:
- Polaris Translation Screw Failures were recently reported to Biomet Spine. These failures are generally described as dissociation of the screw head from the shaft of the Polaris Translation Screw.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
BIOMET Spine, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System. Rx Only. Non-Sterile. Intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system
Product Codes/Lot Numbers:
Multiple Item and Lot numbers. The firm expects all Translation Screw Systems (containing a cobalt chrome component) used and contacted with the SpF Implantable Spine Fusion Stimulator (DC electrical current) to be at risk for this failure mode.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0359-2014
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Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment
Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment