Spine Frontier Inspan compressors Part Number: 11-60004. Inspan compressors provide pressure to drive spikes of Inspan implants into the spinous process bone, resulting in fixation of the implant.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot Numbers: SFP02323, SFP02323R, and SFP02323RR
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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:
SpineFrontier, Inc.
Reason for Recall:
Inspan Compressors may break at weld causing a loss of compression
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Spine Frontier Inspan compressors Part Number: 11-60004. Inspan compressors provide pressure to drive spikes of Inspan implants into the spinous process bone, resulting in fixation of the implant.

Product Codes/Lot Numbers:

Lot Numbers: SFP02323, SFP02323R, and SFP02323RR

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0412-2013

Related Recalls

The PedFuse Pedicle Screw Rod Caliper included with the MISquito Pedicle Screw System may be used incorrectly as the Surgical Technique does not adequately convey the intended use of the design.

Mar 5, 2015 Surgical Instruments Nationwide View Details →