3.75mm x 12mm Fixed Cervical Screws. Components of the Genesys Spine Anterior Cervical Plate System Product Usage: is intended for anterior screw fixation to the cervical spine.
Class I - Dangerous 🏥 Medical Devices
Recalled: February 20, 2013 Genesys Orthopedic Systems Other Medical Devices
Nationwide
What Should You Do?
- Check if you have this product: Part Number: GCSF37512 and Lot Number: 0243
- 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:
- Genesys Orthopedic Systems, LLC
- Reason for Recall:
- Manufacturing residue may be present on the cervical screws. Use of this product may result in patient infection, delayed fusion or non-fusion (pseudarthrosis), inflammatory response, or revision surgery.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
3.75mm x 12mm Fixed Cervical Screws. Components of the Genesys Spine Anterior Cervical Plate System Product Usage: is intended for anterior screw fixation to the cervical spine.
Product Codes/Lot Numbers:
Part Number: GCSF37512 and Lot Number: 0243
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0921-2013