StaXx¿ IB Convex Expandable Implant (25 x 12 x 9 mm), Intervertebral Fusion Device, Lumbar; Catalog Number 11 -1902. Indicated for intervertebral body fusion procedures in skeletally mature patients.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Numbers: 272L08 and 272L09
- 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:
- Spine Wave, Inc.
- Reason for Recall:
- A component Superior endplate manufactured from a different polymer than specified
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
StaXx¿ IB Convex Expandable Implant (25 x 12 x 9 mm), Intervertebral Fusion Device, Lumbar; Catalog Number 11 -1902. Indicated for intervertebral body fusion procedures in skeletally mature patients.
Product Codes/Lot Numbers:
Lot Numbers: 272L08 and 272L09
Distribution:
Distributed in: FL, OR
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2187-2013
Related Recalls
Mislabeled outer carton: Monopolar Probe is listed as 200 x 1.5mm when it should be listed as 280 x 1.5mm