Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the Silex Sacroiliac Fusion System. The soft tissue shields are surgical instrument guides in the Silex Sacroiliac Joint Fusion System for spinal surgery.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Part numbers X079-0096 and X079-0097 with Lot #12320
- 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:
- X Spine Systems Inc
- Reason for Recall:
- Revision B of the tissue shields of the device was 7 mm longer than the previous design.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the Silex Sacroiliac Fusion System. The soft tissue shields are surgical instrument guides in the Silex Sacroiliac Joint Fusion System for spinal surgery.
Product Codes/Lot Numbers:
Part numbers X079-0096 and X079-0097 with Lot #12320
Distribution:
Distributed in: US, FL, MO
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2136-2014
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