Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E Product Usage: The Low Profile Neuro Plating System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Titanium Low Profile Neuro Screw, Self-Drilling, 3mm, part number # 400.833, Lot numbers: 9960359, 9962300, 9967875
- 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:
- Synthes (USA) Products LLC
- Reason for Recall:
- Out of specification at the thread. The thread height of these screws is under-sized. The cross section of the affected area is less than that of conforming screws such that the thread height of the screws is undersized.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E Product Usage: The Low Profile Neuro Plating System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
Product Codes/Lot Numbers:
Titanium Low Profile Neuro Screw, Self-Drilling, 3mm, part number # 400.833, Lot numbers: 9960359, 9962300, 9967875
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1326-2016
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