ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    UDI-DI: 04046964719622
  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:
Fracture or breakage of the spinal fixation arm at the downtube instrument if the 90 degree angle is not met when using the removal key with the spinal fixation system.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R

Product Codes/Lot Numbers:

UDI-DI: 04046964719622

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1428-2022

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 →