ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 15¿

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Part #: 1124.1033; Lot # / UDI #: BAX112VE / (01)00889095069556(10)BAX112VE; BAX126AE / (01)00889095069556(10)BAX126AE; BAX126WE / (01)00889095069556(10)BAX126WE; BAX207AE / (01)00889095069556(10)BAX207AE; BAX244KE / (01)00889095069556(10)BAX244KE; BAX264UE / (01)00889095069556(10)BAX264UE; BAX256DE / (01)00889095069556(10)BAX256DE; BAX348DE / (01)00889095069556(10)BAX348DE; BAX351NE / (01)00889095069556(10)BAX351NE
  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:
Globus Medical, Inc.
Reason for Recall:
Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 15¿

Product Codes/Lot Numbers:

Part #: 1124.1033; Lot # / UDI #: BAX112VE / (01)00889095069556(10)BAX112VE; BAX126AE / (01)00889095069556(10)BAX126AE; BAX126WE / (01)00889095069556(10)BAX126WE; BAX207AE / (01)00889095069556(10)BAX207AE; BAX244KE / (01)00889095069556(10)BAX244KE; BAX264UE / (01)00889095069556(10)BAX264UE; BAX256DE / (01)00889095069556(10)BAX256DE; BAX348DE / (01)00889095069556(10)BAX348DE; BAX351NE / (01)00889095069556(10)BAX351NE

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2856-2020

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