Zeus-P Lumbar Interbody Device
Class I - DangerousWhat Should You Do?
- Check if you have this product: Part Number 1-110926B - Lot Number 128945 and Part Number 1-120922B - Lot Number 128946
- 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:
- Amendia, Inc
- Reason for Recall:
- Labeling error where three boxes in inventory had conflicting patient and primary labels. Evaluation indicated that the primary label and patient label did not match. The primary label matched the label on the inner pouch, but the patient label was incorrect.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Zeus-P Lumbar Interbody Device
Product Codes/Lot Numbers:
Part Number 1-110926B - Lot Number 128945 and Part Number 1-120922B - Lot Number 128946
Distribution:
Distributed in: US, GA, MI, OK, SC, TX, VA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0827-2017
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