Cortoss Bone Augmentation Material, Catalog Nos. 2101-0005 and 2101-0010

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Specific shipments of 2101-0005: Lots A1907006, A1908003; 2101-0010: Lots A1903054, A1906006. UDI 00808232000962, 00808232000979
  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:
Howmedica Osteonics Corp.
Reason for Recall:
Shipments were transported outside of the required refrigerated temperature conditions. Potential hazards if used include nerve damage resulting in paralysis and increased potential for embolism.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Cortoss Bone Augmentation Material, Catalog Nos. 2101-0005 and 2101-0010

Product Codes/Lot Numbers:

Specific shipments of 2101-0005: Lots A1907006, A1908003; 2101-0010: Lots A1903054, A1906006. UDI 00808232000962, 00808232000979

Distribution:

Distributed in: US

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1900-2020

Related Recalls

Class I - Dangerous

Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate Size 4 (lot TYX7OB), is contained in packaging labeled as Triathlon Universal Baseplate Size 3, (lot UZD9IB).

May 19, 2026 Other Medical Devices Nationwide View Details →
Class I - Dangerous

Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate Size 4 (lot TYX7OB), is contained in packaging labeled as Triathlon Universal Baseplate Size 3, (lot UZD9IB).

May 19, 2026 Other Medical Devices Nationwide View Details →
Class I - Dangerous

A potential issue was identified with the torque strength on the external screws of the MICS3 Angled Sagittal Saw Attachment. These screws, which secure the cover to the Angled Saw Housing, may loosen during use and detach from the attachment.

Feb 2, 2026 Other Medical Devices Nationwide View Details →