RIGHT CORONAL BENDER, TEK1940. Instrument used during spinal surgery.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    LOT: 2930902A
  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:
Aesculap Implant Systems LLC
Reason for Recall:
Customized coronal rod benders may deform the implant when used with the spinal system devices.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

RIGHT CORONAL BENDER, TEK1940. Instrument used during spinal surgery.

Product Codes/Lot Numbers:

LOT: 2930902A

Distribution:

Distributed in: CO

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1405-2022

Related Recalls

Potential for the spring to become loose and fall out of the device, if the spring falls out during a surgical procedure, it may enter the patient's body.

Mar 21, 2023 Surgical Instruments Nationwide View Details →